The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Smoothcool Hr System.
| Device ID | K082911 |
| 510k Number | K082911 |
| Device Name: | SMOOTHCOOL HR SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800020106018 | K082911 | 000 |