The following data is part of a premarket notification filed by Lumenis with the FDA for Lumenis Versapulse Powersuite Holmium (ho:yag) And Dual Wavelength (ho:yag/nd:yag) Surgical Lasers And Delivery Devices.
| Device ID | K011703 |
| 510k Number | K011703 |
| Device Name: | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath LUMENIS 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 | 2001-06-01 |
| Decision Date | 2001-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109140599 | K011703 | 000 |
| 07290109140582 | K011703 | 000 |
| 07290109140575 | K011703 | 000 |
| 07290109140568 | K011703 | 000 |
| 07290109140551 | K011703 | 000 |
| 07290109140537 | K011703 | 000 |
| 07290109140520 | K011703 | 000 |