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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260489020425 | K202955 | 000 |