QIU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intense Pulsed Light Device For Managing Dry Eye
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5201
- Medical specialty
- Ophthalmic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Lumenis Stellar M22 (DEN200028) | Lumenis, Ltd. | 2021-02-23 |
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Every clearance here is in the API, with alerts when new ones post.