FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiLight™ Aesthetics
DI: 07290117771006
·
Model: OptiLight Aesthetics
·
LUMENIS BE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OptiLight™ Aesthetics
- Primary DI
- 07290117771006
- Version / Model
- OptiLight Aesthetics
- Company Name
- LUMENIS BE LTD
- Labeler DUNS
- 600763501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-10
- Public Version
- 3
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- efa597d5-6cda-49b1-894b-874b7fd84447
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 |
|---|---|---|---|---|
| QIU | Intense Pulsed Light Device For Managing Dry Eye | Ophthalmic | 886.5201 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 07290117771006 | GS1 |