The following data is part of a premarket notification filed by Quantel Medical, Inc. with the FDA for 308 Dermatological Excimer System.
| Device ID | K073066 |
| 510k Number | K073066 |
| Device Name: | 308 DERMATOLOGICAL EXCIMER SYSTEM |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | QUANTEL MEDICAL, INC. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers QUANTEL MEDICAL, INC. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-30 |
| Decision Date | 2007-12-26 |
| Summary: | summary |