The following data is part of a premarket notification filed by Sunetics International Marketing Group, Llc with the FDA for Sunetics Clinical Bio-stimulation Laser.
| Device ID | K132646 |
| 510k Number | K132646 |
| Device Name: | SUNETICS CLINICAL BIO-STIMULATION LASER |
| Classification | Laser, Comb, Hair |
| Applicant | SUNETICS INTERNATIONAL MARKETING GROUP, LLC 892 STEGER TOWNE RD #44 Rockwall, TX 75032 |
| Contact | John Carullo |
| Correspondent | John Carullo SUNETICS INTERNATIONAL MARKETING GROUP, LLC 892 STEGER TOWNE RD #44 Rockwall, TX 75032 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2013-12-20 |
| Summary: | summary |