The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Modified Versapulse Select Ho:yag And Ho:yag/nd:yag Lasers.
| Device ID | K980685 |
| 510k Number | K980685 |
| Device Name: | MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
| Contact | Anne Worden |
| Correspondent | Anne Worden 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 | 1998-02-23 |
| Decision Date | 1998-05-20 |
| Summary: | summary |