The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Opusduo; Opusduo E; Opusduo Ec; Opus 20; Opus Spectrum.
| Device ID | K040270 |
| 510k Number | K040270 |
| Device Name: | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD. 2400 CONDENSA STREET Santa Clara, CA 95051 |
| Contact | Andrea L Ruth |
| Correspondent | Andrea L Ruth LUMENIS LTD. 2400 CONDENSA STREET Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-05 |
| Decision Date | 2004-12-16 |
| Summary: | summary |