DEN200028 is an FDA 510(k) submission for the Lumenis Stellar M22. This device is classified as a Intense Pulsed Light Device For Managing Dry Eye (Class II - Special Controls, product code QIU).
Submitted by Lumenis, Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on February 23, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5201. An Intense Pulsed Light Device For Managing Dry Eye Is A Prescription Device Intended For Use In The Application Of Intense Pulsed Light Therapy To The Skin. The Device Is Used In Patients With Dry Eye Disease Due To Meibomian Gland Dysfunction, Also Known As Evaporative Dry Eye Or Lipid Deficiency Dry Eye..
| 510(k) Number | DEN200028 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 20, 2020 |
| Decision Date | February 23, 2021 |
| Days to Decision | 309 days |
| Submission Type | Direct |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | QIU — Intense Pulsed Light Device For Managing Dry Eye |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5201 |
| Definition | An Intense Pulsed Light Device For Managing Dry Eye Is A Prescription Device Intended For Use In The Application Of Intense Pulsed Light Therapy To The Skin. The Device Is Used In Patients With Dry Eye Disease Due To Meibomian Gland Dysfunction, Also Known As Evaporative Dry Eye Or Lipid Deficiency Dry Eye. |