FDA UDI
In Commercial Distribution
🇺🇸 United States
ACTIVO
DI: 08800017500102
·
Model: 1.0
·
Daeju Medi Tech Engineering
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACTIVO
- Primary DI
- 08800017500102
- Version / Model
- 1.0
- Catalog Number
- DJMD0004
- Company Name
- Daeju Medi Tech Engineering
- Labeler DUNS
- 694492044
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-30
- Public Version
- 1
- Public Version Date
- 2024-10-08
- Public Version Status
- New
- Public Device Record Key
- 7b23c4c7-0784-41c0-b823-1a9cb74c712a
Device Description
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)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45223 | Multi-modality skin surface treatment system generator | A mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). Dedicated applicators are used to apply the different energies to the skin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800017500102 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242206 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius