The following data is part of a premarket notification filed by American Optisurgical, Inc. with the FDA for Visual Phacoemulsification System, Model 551.
| Device ID | K080803 |
| 510k Number | K080803 |
| Device Name: | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 |
| Classification | Unit, Phacofragmentation |
| Applicant | AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Contact | David Salzberg |
| Correspondent | David Salzberg AMERICAN OPTISURGICAL, INC. 25501 ARCTIC OCEAN Lake Forest, CA 92630 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-21 |
| Decision Date | 2008-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039020346 | K080803 | 000 |
| 00850039020339 | K080803 | 000 |
| 00850039020070 | K080803 | 000 |
| 00850039020063 | K080803 | 000 |
| 00850039020056 | K080803 | 000 |