| Primary Device ID | 00841494100032 |
| NIH Device Record Key | 28c48f71-822c-49b8-b3d6-6b93c0f86f44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SculpSure laser assembly |
| Version Model Number | 100-7026-010 |
| Company DUNS | 780318028 |
| Company Name | Cynosure, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841494100032 [Primary] |
| PKT | Laser for disruption of adipocyte cells for aesthetic use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-26 |
| 00841494108090 - ASSY, FOCUS ARRAY, PLATINUM, PICOSURE | 2022-08-16 ASSY, FOCUS ARRAY, PLATINUM, PICOSURE |
| 00841494103507 - Vectus - Base Module Reman | 2022-08-15 Vectus - Base Module Reman |
| 00841494103774 - ICON CONTROL MODULE REMAN | 2022-08-15 ICON CONTROL MODULE REMAN |
| 00841494100230 - ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300 | 2021-08-13 ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300 |
| 00841494100537 - ASSY, FINAL LASER, PICO300 | 2021-08-13 ASSY, FINAL LASER, PICO300 |
| 00841494100520 - ASSY, 1540 HANDPIECE, ICON | 2021-07-26 ASSY, 1540 HANDPIECE, ICON |
| 00841494102272 - 1540 HANDPIECE ICON, REMANUFACTURED | 2021-07-26 1540 HANDPIECE ICON, REMANUFACTURED |
| 00841494105105 - 60MM HANDPIECE W/ACC, TEMPSURE | 2021-07-26 60MM HANDPIECE W/ACC, TEMPSURE |