OptiLight
- Primary DI
- 07290117771815
- Brand
- OptiLight
- Company
- LUMENIS BE LTD
- Model
- NA
- Published
- 2023-03-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| QIU | Intense Pulsed Light Device For Managing Dry Eye |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| QIU | Intense Pulsed Light Device For Managing Dry Eye | Ophthalmic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07290117771815 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07290117771815 | 07290117771815 | 7290117771815 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 600763501
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07290117772737 | Multi-Spot™ Nd:YAG Head | NA | 2025-12-21 | |
| 07290117772744 | M22™ Q-Switched Head | NA | 2025-12-21 | |
| 07290117772751 | Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kit | NA | 2025-12-21 | |
| 07290117772768 | Stellar M22™ Q-Switched Nd:YAG Upgrade Kit | NA | 2025-12-21 | |
| 07290117772645 | Black Stellar XPL HP | NA | 2025-09-08 | |
| 07290117772652 | Stellar XPL Module Kit | NA | 2025-09-08 | |
| 07290117772447 | FoLiCool™ Tip | NA | 2024-03-17 | |
| 07290117772522 | FoLix™ | NA | 2024-03-17 | |
| 07290117772539 | FoLix™ Handpiece | NA | 2024-03-17 | |
| 07290117772393 | LUSTER System | NA | 2024-01-22 | |
| 07290117772409 | LUSTER Handpiece | NA | 2024-01-22 | |
| 07290117772416 | LUSTER Tip, Round | NA | 2024-01-22 | |
| 17290117772420 | OPT™ Shields | NA | 2023-12-26 | |
| 07290117771372 | AcuPulse | NA | 2023-12-04 | |
| 07290117771389 | AcPulse W | NA | 2023-12-04 | |
| 07290117771396 | SurgiTouch™ Scanning Handpiece Set | NA | 2023-12-04 | |
| 07290117771402 | SurgiTouch™ Scanning Handpiece 125mm | NA | 2023-12-04 | |
| 07290117771419 | SurgiTouch™ Scanning Handpiece 260mm | NA | 2023-12-04 | |
| 07290117771426 | SurgiTouch™ Scanning Handpiece 200mm | NA | 2023-12-04 | |
| 07290117771433 | AcuPulse Incisional Handpiece 125 mm | NA | 2023-12-04 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07290117771716 | Digital OptiLight Aesthetics | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771723 | Digital OptiLight | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771747 | Opti-Tip | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771761 | OPT Handpiece | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771778 | OPT Module Kit | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771785 | OptiLight IPL Handpiece | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771808 | OptiLight IPL Module Kit | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771891 | OptiLight IPL MODALITY FILTERS KIT | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771907 | IPL Upgrade Kit for OptiLight | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771914 | OptiLight IPL Handpiece | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771921 | OptiLight Filter | LUMENIS BE LTD | QIU | 2023-03-21 |
| 07290117771006 | OptiLight™ Aesthetics | LUMENIS BE LTD | QIU | 2022-08-10 |
| 07290109145303 | OptiLight IPL Handpiece NF | LUMENIS LTD. | QIU | 2021-09-06 |
| 07290109144740 | OptiLight IPL Module Kit | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109144894 | OPT Filter | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109144900 | Rosacea I-III Filter | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109144917 | Rosacea IV-V Filter | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145082 | OPT Module Kit | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145099 | OPT Handpiece | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145105 | OptiLight IPL Handpiece | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145259 | Opti-Tip Treatment Kit | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145266 | Vanilla to OptiLight Upgrade Kit | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145273 | OptiLight IPL Upgrade Kit | LUMENIS LTD. | QIU | 2021-07-25 |
| 07290109145204 | Stellar Optima System upgrade kit | LUMENIS LTD. | QIU | 2021-05-27 |
| 17290109145126 | Stellar Optima Treatment Kit | LUMENIS LTD. | QIU | 2021-04-13 |