Submission Details
| 510(k) Number | K901605 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 1990 |
| Decision Date | December 13, 1990 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
Dec 1990
Decision
252d
Days
Class 2
Risk
About This 510(k) Submission
K901605 is an FDA 510(k) clearance for the PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA., a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II — Special Controls, product code LXS), submitted by Phoenix Laser Systems, Inc. (St.Petersburg, US). The FDA issued a Cleared decision on December 13, 1990, 252 days after receiving the submission on April 5, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4392.
Device Classification
| Product Code | LXS — Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4392 |
Manufacturer
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