# LF1 applicator AS100007

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/lf1-applicator-as100007>
- Manufacturer: [Venus Concept Inc.](https://devicerts.com/manufacturers/venus-concept-inc) (United States)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: PBX, GEI
- EMDN: X0599 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER
- GMDN: Radio-frequency skin contouring system applicator, bipolar (45213)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00810060830864 · UDI-DI 00810060830864 · registered 2026-11-06 · status: Active
- **GUDID** · FDA 510(k) · United States · K191528 · decision 2019-09-06 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 00810060830864 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K143554 · decision 2015-08-04 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: LF1 applicator [FDA GUDID (AccessGUDID)]
- Generic name: Radio-frequency skin contouring system applicator, bipolar [FDA GUDID (AccessGUDID)]
- Model / reference: AS100007 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00810060830864 [EUDAMED]; 07290016540031 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00810060830864 [EUDAMED]
- FDA product code: PBX [FDA GUDID (AccessGUDID)]; GEI [FDA GUDID (AccessGUDID)]
- EMDN code: X0599 [EUDAMED]
- GMDN term: Radio-frequency skin contouring system applicator, bipolar (45213) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4400 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Spain [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: LF1 applicator AS100007, Venus Concept Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/lf1-applicator-as100007 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/lf1-applicator-as100007.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/lf1-applicator-as100007
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.