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 |