The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for Portalase 300 Carbon Dioxide Surg Laser Dermatolog.
| Device ID | K854472 |
| 510k Number | K854472 |
| Device Name: | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1986-02-11 |