FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OptiLight™
DI: 07290109145280
·
Model: OptiLight™
·
LUMENIS LTD.
Product Codes
4
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OptiLight™
- Primary DI
- 07290109145280
- Version / Model
- OptiLight™
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-25
- Public Version
- 4
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- eaaab725-4dab-4999-84d1-e520265a3ef8
- Distribution End Date
- 2023-08-10
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 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | 878.4810 | 2 |
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | Ophthalmic | 886.5201 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45220 | Multi-modality skin surface treatment system | An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation 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). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin. | No | Active |
| 60386 | Intense pulsed light dry eye therapy unit | A portable mains electricity (AC-powered) device intended to treat meibomian blepharitis (dry eye syndrome) by targeting the skin surrounding the meibomian glands (around the eyelid) with intense pulsed light (IPL). It consists of a generator connected to a light-emitting handpiece, and typically includes skin contact gel and light shielding safety glasses. It is intended to be operated by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109145280 | GS1 |