The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Selecta 7000 Frequency Doubled, Q-switched Nd:yag Ophthalmic Laser.
| Device ID | K004006 |
| 510k Number | K004006 |
| Device Name: | SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Karen Baker |
| Correspondent | Karen Baker 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 | 2000-12-26 |
| Decision Date | 2001-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143231 | K004006 | 000 |