| Primary Device ID | 00816417021459 |
| NIH Device Record Key | cf327476-8f71-4686-9efb-205fbaba8913 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoolSculpting Solo |
| Version Model Number | CS-S2-002-D-00 |
| Company DUNS | 809152916 |
| Company Name | Zeltiq Aesthetics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-935-8471 |
| support@zeltiq.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816417021459 [Primary] |
| OOK | Dermal Cooling Pack/Vacuum/Massager |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2019-11-07 |
| 10816417020152 - CoolSmooth Foam Borders | 2025-06-30 CoolSmooth Foam Borders |
| 10816417020541 - CoolSmooth Securement System | 2025-06-30 Securement System, Qty 12 |
| 10816417020558 - CoolSmooth Securement System | 2025-06-30 CoolSmooth Securement Strap, Short, Qty |
| 10816417020565 - CoolSmooth PRO Securement Straps | 2025-06-30 Assembly Pouched Securement Straps, CoolSmooth |
| 10816417020671 - CoolAdvantage Gasket | 2025-06-30 Gasket, 24-Pack, CoolAdvantage |
| 10816417020916 - CoolAdvantage Petite Gasket - 24 Pack | 2025-06-30 CoolAdvantage Petite Gasket - 24 Pack |
| 00816417022746 - Curve 135 (C135) Applicator | 2024-04-03 CoolSculpting System Applicator Curve 135 (C135) |
| 00816417021008 - CoolCurve Applicator | 2021-08-20 CoolCurve Applicator |