The following data is part of a premarket notification filed by Raja Trading Company, Inc. with the FDA for Oxylight 2.0.
| Device ID | K202175 |
| 510k Number | K202175 |
| Device Name: | OxyLight 2.0 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Raja Trading Company, Inc. 2801 Juniper Street, Suite 2 Fairfax, VA 22031 |
| Contact | Christine K. Powers |
| Correspondent | Yolanda R. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | GEX |
| Subsequent Product Code | GFE |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G050OXYLIGHTIONIX0 | K202175 | 000 |
| G050IONIXLIGHT0 | K202175 | 000 |