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 |