The following data is part of a premarket notification filed by Medical Laser Research & Development Corp. with the FDA for Dermascan Laser Surgical Handpiece.
| Device ID | K860083 |
| 510k Number | K860083 |
| Device Name: | DERMASCAN LASER SURGICAL HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER RESEARCH & DEVELOPMENT CORP. 46 CLARK ST. Malden, MA 02148 |
| Contact | Donna Bourgelais |
| Correspondent | Donna Bourgelais MEDICAL LASER RESEARCH & DEVELOPMENT CORP. 46 CLARK ST. Malden, MA 02148 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-09 |
| Decision Date | 1986-08-07 |