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

• 08800017500195 - NOABLE LASER: 2025-03-21 NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode las
• 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