The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Modification To Cutera Er:ysgg Laser Handpiece.
| Device ID | K080530 |
| 510k Number | K080530 |
| Device Name: | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-26 |
| Decision Date | 2008-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722022844 | K080530 | 000 |