ACTIVO DJMD0004
GUDID 08800017500102
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
Daeju Medi Tech Engineering
Multi-modality skin surface treatment system generator| Primary Device ID | 08800017500102 |
| NIH Device Record Key | 7b23c4c7-0784-41c0-b823-1a9cb74c712a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACTIVO |
| Version Model Number | 1.0 |
| Catalog Number | DJMD0004 |
| Company DUNS | 694492044 |
| Company Name | Daeju Medi Tech Engineering |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800017500102 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K242206
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-08 |
| Device Publish Date | 2024-09-30 |
Devices Manufactured by Daeju Medi Tech Engineering
| 08800017500102 - ACTIVO | 2024-10-08Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm) |
| 08800017500102 - ACTIVO | 2024-10-08 Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and b |
| 08800017500126 - AROMA GRAND | 2022-03-21 The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin t |
Trademark Results [ACTIVO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTIVO 98636303 not registered Live/Pending |
Dreamus Company 2024-07-08 |
 ACTIVO 90126660 not registered Live/Pending |
Activo Apparel llc 2020-08-20 |
 ACTIVO 87486818 not registered Live/Pending |
Activo Nutrition LLC 2017-06-13 |
 ACTIVO 86020922 not registered Dead/Abandoned |
Activo International Bank, Inc. 2013-07-26 |
 ACTIVO 85407248 not registered Dead/Abandoned |
EW Nutrition USA, Inc. 2011-08-25 |
 ACTIVO 79210698 5461334 Live/Registered |
Dreamus Company 2017-04-18 |
 ACTIVO 77211761 3686611 Live/Registered |
Playworld Systems, Inc. 2007-06-21 |
 ACTIVO 77151350 3460314 Dead/Cancelled |
Activo, Inc. 2007-04-08 |
 ACTIVO 76534789 not registered Dead/Abandoned |
Anystream, Inc. 2003-07-22 |
 ACTIVO 75394017 2295047 Dead/Cancelled |
DAIMLER-BENZ AKTIENGESELLSCHAFT 1997-11-21 |
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