Submission Details
| 510(k) Number | K892058 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 1989 |
| Decision Date | June 15, 1989 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
ISL QC 2000
Jun 1989
Decision
78d
Days
Class 2
Risk
About This 510(k) Submission
K892058 is an FDA 510(k) clearance for the ISL QC 2000, a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II — Special Controls, product code LXS), submitted by Intelligent Surgical Lasers, Inc. (San Diego, US). The FDA issued a Cleared decision on June 15, 1989, 78 days after receiving the submission on March 29, 1989. 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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