The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Model 900s Intraocular Probe.
| Device ID | K812219 |
| 510k Number | K812219 |
| Device Name: | MODEL 900S INTRAOCULAR PROBE |
| Classification | Laser, Ophthalmic |
| Applicant | LUMENIS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-06 |
| Decision Date | 1981-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290109142781 | K812219 | 000 |
| 07290109140742 | K812219 | 000 |
| 07290109140735 | K812219 | 000 |
| 17290109140725 | K812219 | 000 |