The following data is part of a premarket notification filed by Contour Research, Llc with the FDA for Contour Light Cl-100.
Device ID | K202955 |
510k Number | K202955 |
Device Name: | Contour Light CL-100 |
Classification | Fat Reducing Low Level Laser |
Applicant | Contour Research, LLC 200 S Virginia St #8 Reno, NV 89501 |
Contact | Doug Dreier |
Correspondent | Shepard G. Bentley Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677 |
Product Code | OLI |
CFR Regulation Number | 878.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2021-05-19 |