The following data is part of a premarket notification filed by Zuko, Inc. with the FDA for Acne Light Therapy Wand.
| Device ID | K160691 |
| 510k Number | K160691 |
| Device Name: | Acne Light Therapy Wand |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | ZUKO, INC. 208 UPLAND WAY Wayne, PA 19087 |
| Contact | Jay Tapper |
| Correspondent | M.joyce Heinrich TEXAS APPLIED BIOMEDICAL SERVICES (T.A.B.S.) 12101 CULLEN BLVD, SUITE A Houston, TX 77047 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-11 |
| Decision Date | 2016-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00070501101315 | K160691 | 000 |