Data / Medical devices / Intense Pulsed Light Device For Managing Dry Eye
Intense Pulsed Light Device For Managing Dry Eye (QIU): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Intense Pulsed Light Device For Managing Dry Eye (product code QIU, Class 2, 21 CFR 886.5201). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on February 23, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QIU
- Device class
- 2
- Regulation
- 886.5201
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Israel | 2 |
| United States | 1 |
Makers of Intense Pulsed Light Device For Managing Dry Eye
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lumenis Be Ltd | Yokneam, Ha Zafon 2069236 Haifa, Israel | Manufacturer, Specification developer | 1 | February 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Atena (from The Imco Group) Ltd | Nesher Haifa, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RH Usa, Inc. | Livermore, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.