K812219 is an FDA 510(k) clearance for the MODEL 900S INTRAOCULAR PROBE. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Lumenis, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981, 102 days after receiving the submission on August 6, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K812219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1981 |
| Decision Date | November 16, 1981 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |