K925663 is an FDA 510(k) clearance for the HGM ASPIRATING ENDOOCULAR(TM) PROBE. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 17, 1993, 280 days after receiving the submission on November 10, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K925663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1992 |
| Decision Date | August 17, 1993 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |