The following data is part of a premarket notification filed by Verilux with the FDA for Clearwave Phototherapy System For Acne, Model: Cwst2.
| Device ID | K091125 |
| 510k Number | K091125 |
| Device Name: | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 |
| Classification | Powered Light Based Non-laser Surgical Instrument |
| Applicant | VERILUX 391 BRIDGE POINT DR. South St. Paul, MN 55075 |
| Contact | Ryan Douglas |
| Correspondent | Ryan Douglas VERILUX 391 BRIDGE POINT DR. South St. Paul, MN 55075 |
| Product Code | ONE |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2010-09-03 |
| Summary: | summary |