Intense Pulsed Light Device For Managing Dry Eye
The Intense Pulsed Light Device For Managing Dry Eye is a prescription ophthalmic device that applies intense pulsed light therapy to the periocular skin in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative or lipid deficiency dry eye. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 886.5201 within the Ophthalmic medical specialty. The product code is QIU. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QIU
- Device Class
- FDA class 2
- Regulation Number
- 886.5201
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200028 | Lumenis Stellar M22 | Feb 23, 2021 | Unknown | Lumenis, Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.