K852548 is an FDA 510(k) clearance for the ATL 225 MW TRAIL LENS SET. This device is classified as a Frame, Trial, Ophthalmic (Class I - General Controls, product code HPA).
Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on July 31, 1985, 49 days after receiving the submission on June 12, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1415.
| 510(k) Number | K852548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1985 |
| Decision Date | July 31, 1985 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPA — Frame, Trial, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1415 |