The following data is part of a premarket notification filed by Zeltiq Aesthetics with the FDA for Zeltiq Aesthetics Cln1 Dermal Cooling Device.
| Device ID | K080118 |
| 510k Number | K080118 |
| Device Name: | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZELTIQ AESTHETICS 4698 WILLOW ROAD Pleasanton, CA 94588 |
| Contact | Donald V Johnson |
| Correspondent | Donald V Johnson ZELTIQ AESTHETICS 4698 WILLOW ROAD Pleasanton, CA 94588 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-17 |
| Decision Date | 2008-05-02 |
| Summary: | summary |