Epileve Applicator Service Pack UDI Label
- Primary DI
- 07290016541984
- Brand
- Epileve Applicator Service Pack UDI Label
- Company
- VENUS CONCEPT LTD
- Model
- SPK230010
- Device description
- The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general andplastic surgery applications for:• Hair removal;• Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measuredat 6, 9, and 12 months after the completion of a treatment regimen); and• Treatment of pseudofolliculitis barbae.
- Published
- 2021-07-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| GEX | Powered Laser Surgical Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K200786 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07290016541984 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07290016541984 | 07290016541984 | 7290016541984 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dermatological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 533127663
- Device count
- 1
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07290016541281 | BLISS SYSTEM | BL000001 | 2021-07-14 | |
| 07290016541564 | BODY LASER APPLICATOR SERVICE PACK, Bliss | SPK160000 | 2021-07-14 | |
| 07290016541625 | BODY LASER APPLICATOR BLISS | AS160004 | 2021-07-14 | |
| 07290016541724 | Belt Bliss | AS160027 | 2021-07-14 | |
| 07290016540765 | Venus Legacy CX - LB2 applicator (new design) | AS100063 | 2018-11-18 | |
| 07290016540963 | Venus Legacy CX - LF2 applicator (new design) | AS100075 | 2018-11-18 | |
| 07290016541618 | (MP)2 APPLICATOR BLISS | AS160043 | 2021-07-14 | |
| 07290016541717 | (MP)2 APPLICATOR SERVICE PACK, Bliss | SPK160001 | 2021-07-14 | |
| 07290016540000 | Venus Legacy | LE120004 | 2016-09-24 | |
| 07290016540055 | Venus Legacy kit | PK000008 | 2016-09-24 | |
| 07290016540079 | LB1 + LF1 kit | PK000041 | 2016-09-24 | |
| 07290016540086 | Venus Legacy - 110V System | LE100004 | 2018-11-18 | |
| 07290016540109 | Venus Legacy | LE240004 | 2016-09-24 | |
| 07290016540116 | Venus Legacy kit | PK000002 | 2016-09-24 | |
| 07290016541472 | Venus Legacy 240V - Nikao | AS100005NI | 2018-11-18 | |
| 07290016541533 | Venus Legacy 110V - Nikao | LE120004NI | 2018-11-18 | |
| 27290016541179 | HR 690XL Light Block package | PK000324 | 2020-04-23 | |
| 27290016541216 | HR690 Light Block package | PK000328 | 2020-04-23 | |
| 27290016541223 | ACDUAL Light Block package | PK000344 | 2020-04-23 | |
| 07290016541168 | Venus Versa - HR 650XL light block package | PK000323 | 2018-11-18 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06974851082079 | BVLASER | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | 2026-07-16 |
| 06974851082086 | BVLASER | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | 2026-07-16 |
| 06974851088019 | BVLASER | Nanjing Bestview Laser S&T Co.,Ltd. | GEX | 2026-07-16 |
| 08800020106322 | TRI-BEAM | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109446 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109453 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109460 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109477 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109484 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109491 | TRI-BEAM Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109507 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109514 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109521 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109538 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109545 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109552 | TRI-BEAM PRO Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109651 | Edge Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109668 | Edge Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109675 | Edge Handpiece | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109682 | Edge Guide Tip | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109699 | Edge Guide Tip | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109705 | Edge Guide Tip | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109712 | Edge Guide Tip | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109729 | Edge Guide Tip | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109989 | Footswitch | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020109996 | Footswitch | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020110008 | Footswitch | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020110275 | SMOOTHCOOL Filter | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020110282 | SMOOTHCOOL Filter | Jeisys Medical Inc. | GEX | 2026-07-16 |
| 08800020110299 | SMOOTHCOOL Filter | Jeisys Medical Inc. | GEX | 2026-07-16 |