The following data is part of a premarket notification filed by Derma-lase Co. with the FDA for Multiline; Dly-1.
| Device ID | K932156 |
| 510k Number | K932156 |
| Device Name: | MULTILINE; DLY-1 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DERMA-LASE CO. 3 MAIN ST. Hopkinton, MA 01748 |
| Contact | Michael Barretti |
| Correspondent | Michael Barretti DERMA-LASE CO. 3 MAIN ST. Hopkinton, MA 01748 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-04 |
| Decision Date | 1993-10-15 |