Cellulize
Fat Reducing Low Level Laser
Ward Photonics LLC
The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Cellulize.
Pre-market Notification Details
| Device ID | K180338 |
| 510k Number | K180338 |
| Device Name: | Cellulize |
| 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 | 2018-02-07 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860925000314 | K180338 | 000 |
Trademark Results [Cellulize]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLULIZE 86129258 4627510 Live/Registered |
BLUE WATER INNOVATIONS, LLC 2013-11-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.