The following data is part of a premarket notification filed by Lasersafe, Inc. with the FDA for Lasersafe Eye Shields.
| Device ID | K852404 |
| 510k Number | K852404 |
| Device Name: | LASERSAFE EYE SHIELDS |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | LASERSAFE, INC. 641 RIDGEFIELD AVE. Pittsburgh, PA 15216 |
| Contact | Teeple, M.d. |
| Correspondent | Teeple, M.d. LASERSAFE, INC. 641 RIDGEFIELD AVE. Pittsburgh, PA 15216 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-06 |
| Decision Date | 1985-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841785107703 | K852404 | 000 |