The following data is part of a premarket notification filed by Wellquest Intl., Inc. with the FDA for Nubrilliance Pulsed Light Hair Removal Device.
| Device ID | K132518 |
| 510k Number | K132518 |
| Device Name: | NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | WELLQUEST INTL., INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701 |
| Contact | Robert Seiple, Rac |
| Correspondent | Robert Seiple, Rac WELLQUEST INTL., INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2014-08-17 |
| Summary: | summary |