The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model 545-45 Laser For Derma., Pod., Surgical.
| Device ID | K860974 |
| 510k Number | K860974 |
| Device Name: | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BRITT CORP., INC. C/O WECK SURGICAL SYSTEMS INC. 686 OLD WILLETS PATH Hauppague, NY 11788 |
| Contact | Jeffrey Green |
| Correspondent | Jeffrey Green BRITT CORP., INC. C/O WECK SURGICAL SYSTEMS INC. 686 OLD WILLETS PATH Hauppague, NY 11788 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-14 |
| Decision Date | 1986-07-07 |