The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lightsheer Duet Laser System.
| Device ID | K053628 |
| 510k Number | K053628 |
| Device Name: | LIGHTSHEER DUET LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Connie Hoy |
| Correspondent | Connie Hoy LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-29 |
| Decision Date | 2006-04-07 |
| Summary: | summary |