The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Smoothcool.
| Device ID | K092326 |
| 510k Number | K092326 |
| Device Name: | SMOOTHCOOL |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | JEISYS MEDICAL, INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls JEISYS MEDICAL, INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 8800020103024 | K092326 | 000 |