| Primary Device ID | 00850017374218 |
| NIH Device Record Key | 1e825eb6-afb4-42b5-a2f7-1b2a25d30b0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EpilMe Applicator |
| Version Model Number | 300-1701 |
| Company DUNS | 117030786 |
| Company Name | NEAUVIA NORTH AMERICA, 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017374218 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-11 |
| Device Publish Date | 2022-10-03 |
| 00850017374188 - LaserMe | 2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure |
| 00850017374201 - EpilMe System | 2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen |
| 00850017374218 - EpilMe Applicator | 2022-10-11Handpiece applicator for EpilMe System |
| 00850017374218 - EpilMe Applicator | 2022-10-11 Handpiece applicator for EpilMe System |
| 00850017374126 - Sectum System | 2021-10-05 |
| 00850017374133 - Sectum Precise (Face) Applicator | 2021-10-05 |
| 00850017374140 - Sectum Body Applicator | 2021-10-05 |
| 00850017374157 - Sectum Foot Switch | 2021-10-05 Foot switch for the Sectum System |
| 00850017374164 - Sectum Cable Body Applicator | 2021-10-05 |