The following data is part of a premarket notification filed by Medical Laser Solutions with the FDA for Fotona Skinlight Plus Nd: Yag System.
| Device ID | K972368 |
| 510k Number | K972368 |
| Device Name: | FOTONA SKINLIGHT PLUS ND: YAG SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER SOLUTIONS 304 NEWBURY ST., #339 Boston, MA 02115 |
| Contact | Iain D Miller |
| Correspondent | Iain D Miller MEDICAL LASER SOLUTIONS 304 NEWBURY ST., #339 Boston, MA 02115 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-25 |
| Decision Date | 1997-09-23 |
| Summary: | summary |