The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Lumenis Family Of Ultrapulse Surgitouch Co2 Surgical Lasers.
| Device ID | K030147 |
| 510k Number | K030147 |
| Device Name: | LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Contact | Anna Worden |
| Correspondent | Anna Worden LUMENIS, LTD. 2400 CONDENSA ST. 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 | 2003-01-15 |
| Decision Date | 2003-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290117771693 | K030147 | 000 |
| 07290117771679 | K030147 | 000 |