The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Ultraslim Digital, Ultrasmooth Digital.
| Device ID | K202361 |
| 510k Number | K202361 |
| Device Name: | UltraSlim Digital, UltraSmooth Digital |
| Classification | Fat Reducing Low Level Laser |
| Applicant | Ward Photonics LLC 1980 N Atlantic Avenue Cocoa Beach, FL 32931 |
| Contact | Terry Ward |
| Correspondent | Jeff Brown Jeff Brown Lifescience 1260 Bell View Circle Sandy, UT 84094 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860925000345 | K202361 | 000 |
| 00860925000338 | K202361 | 000 |