Oxylight
Powered Laser Surgical Instrument
RAJA Trading Company, Inc.
The following data is part of a premarket notification filed by Raja Trading Company, Inc. with the FDA for Oxylight.
Pre-market Notification Details
| Device ID | K200104 |
| 510k Number | K200104 |
| Device Name: | Oxylight |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RAJA Trading Company, Inc. 801 South Olive Avenue, Suite 124 West Palm Beach, FL 33401 |
| Contact | Robert J Adipietro |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114 |
| Product Code | GEX |
| Subsequent Product Code | ISA |
| Subsequent Product Code | NFO |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-06-04 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G050OXYLIGHT0 | K200104 | 000 |
Trademark Results [Oxylight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYLIGHT 85497817 4189989 Live/Registered |
Raja Trading Company, Inc. 2011-12-16 |
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