The following data is part of a premarket notification filed by Wellray Medical Laser, Inc. with the FDA for Softcure 96.
| Device ID | K170068 |
| 510k Number | K170068 |
| Device Name: | Softcure 96 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | WELLRAY MEDICAL LASER, INC. 216 Moores Run Rd. Wardensville, WV 26851 |
| Contact | Richard O Deroberts |
| Correspondent | Richard O Deroberts WELLRAY MEDICAL LASER, INC. 216 Moores Run Rd. Wardensville, WV 26851 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-05-05 |
| Summary: | summary |