The following data is part of a premarket notification filed by Wellquest International, Inc. with the FDA for Nubrilliance Light Pain Therapy.
Device ID | K150554 |
510k Number | K150554 |
Device Name: | NuBrilliance Light Pain Therapy |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | WELLQUEST INTERNATIONAL, INC. 230 FIFTH AVE SUITE 800 New York, NY 10001 |
Contact | Yveth Kan |
Correspondent | Carrie Hetrick EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-04 |
Decision Date | 2015-10-06 |
Summary: | summary |