QIU — Intense Pulsed Light Device For Managing Dry Eye Class II
FDA product code QIU covers "Intense Pulsed Light Device For Managing Dry Eye", a Class II medical device regulated under 21 CFR 886.5201. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QIU
- Device Class
- Class II
- Regulation Number
- 886.5201
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200028 | lumenis | Lumenis Stellar M22 | February 23, 2021 |