The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System In Combination With The Coherent Argons.
| Device ID | K973470 |
| 510k Number | K973470 |
| Device Name: | COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
| Contact | Karen Baker |
| Correspondent | Karen Baker LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-12 |
| Decision Date | 1997-12-09 |
| Summary: | summary |