The following data is part of a premarket notification filed by Surgilase, Inc. with the FDA for Surgilase Yag 100 For Gynecology Use.
| Device ID | K881499 |
| 510k Number | K881499 |
| Device Name: | SURGILASE YAG 100 FOR GYNECOLOGY USE |
| Classification | Laser, Neodymium:yag, Pulmonary Surgery |
| Applicant | SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Contact | Timothy J Shea |
| Correspondent | Timothy J Shea SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Product Code | LLO |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-04-29 |