The following data is part of a De Novo classification by Lumenis Ltd. with the FDA for Lumenis Stellar M22.
| DeNovo ID | DEN200028 |
| Device Name: | Lumenis Stellar M22 |
| Classification | Intense Pulsed Light Device For Managing Dry Eye |
| Applicant | Lumenis Ltd. 6 Hakidma Street Po Box 240 Yokneam, IL 2069204 |
| Contact | Shlomit Segman |
| Product Code | QIU |
| CFR Regulation Number | 886.5201 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ophthalmic |
| Classification Advisory | Ophthalmic |
| Type | Direct |
| Date Received | 2020-04-20 |
| Decision Date | 2021-02-23 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290109145126 | DEN200028 | 000 |
| 07290109145303 | DEN200028 | 000 |
| 07290109144740 | DEN200028 | 000 |
| 07290109144894 | DEN200028 | 000 |
| 07290109144900 | DEN200028 | 000 |
| 07290109144917 | DEN200028 | 000 |
| 07290109145082 | DEN200028 | 000 |
| 07290109145099 | DEN200028 | 000 |
| 07290109145105 | DEN200028 | 000 |
| 07290109145259 | DEN200028 | 000 |
| 07290109145266 | DEN200028 | 000 |
| 07290109145273 | DEN200028 | 000 |
| 07290109145280 | DEN200028 | 000 |
| 07290109145198 | DEN200028 | 000 |
| 07290109145204 | DEN200028 | 000 |
| 07290109144641 | DEN200028 | 000 |
| 07290117771006 | DEN200028 | 000 |