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 |