DermaV
GUDID 08809447655291
DermaV_MANUAL_REV00_USA
Lutronic Corporation
Dermatological solid-state laser system| Primary Device ID | 08809447655291 |
| NIH Device Record Key | 594aec85-3871-4141-bb2d-c2234d96e8d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DermaV |
| Version Model Number | DermaV_MANUAL_REV00_USA |
| Company DUNS | 688282516 |
| Company Name | Lutronic Corporation |
| 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 | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com | |
| Phone | 888-588-7644 |
| athourot@lutronic-usa.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809447655291 [Primary] |
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 | 2022-03-07 |
| Device Publish Date | 2022-02-25 |
On-Brand Devices [DermaV]
| 08809447655321 | COMPL_BODY_ICD_S_case |
| 08809447655314 | TIP_MIDDLE_O_TYPE |
| 08809447655307 | ROLLER SET_GL19 |
| 08809447655291 | DermaV_MANUAL_REV00_USA |
| 08809447655284 | FOOT SWITCH_GL19 |
| 08809447655277 | COMPL_BODY_ICD_S_DermaV_220V / USA / ICD |
| 08809447655260 | WINDOW HOLDER ASSY_GL19 |
| 08809447655253 | COMPL_POLE_FIBER |
| 08809447655246 | HANDPIECE ASSY_ST-A_GL19 |
| 08809447655239 | CARTRIDGE_DermaV_2, 3, 5_7, 8_10_12, 12_14_16, 3X10 mm, FRACTIONAL |
Trademark Results [DermaV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DERMAV 98666408 not registered Live/Pending |
Lutronic Corporation 2024-07-25 |
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