| Primary Device ID | 07290016541984 |
| NIH Device Record Key | 12de2d6a-9bf9-448e-b713-9573e4c7448d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epileve Applicator Service Pack UDI Label |
| Version Model Number | SPK230010 |
| Company DUNS | 533127663 |
| Company Name | VENUS CONCEPT LTD |
| 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 |
| 07290016541632 - BLISS SYSTEM | 2021-07-22 The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen
and flanks in individuals with |
| 07290016541564 - BODY LASER APPLICATOR SERVICE PACK, Bliss | 2021-07-22 |
| 07290016541618 - (MP)2 APPLICATOR BLISS | 2021-07-22 |
| 07290016541625 - BODY LASER APPLICATOR BLISS | 2021-07-22 |
| 07290016541717 - (MP)2 APPLICATOR SERVICE PACK, Bliss | 2021-07-22 |
| 07290016541724 - Belt Bliss | 2021-07-22 |
| 07290016541984 - Epileve Applicator Service Pack UDI Label | 2021-07-22The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and
plastic surgery applications for:
• Hair removal;
• Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured
at 6, 9, and 12 months after the completion of a treatment regimen); and
• Treatment of pseudofolliculitis barbae. |
| 07290016541984 - Epileve Applicator Service Pack UDI Label | 2021-07-22 The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and
plastic |
| 27290016541179 - HR 690XL Light Block package | 2020-05-01 |