# K232192: Venus Versa PRO System

- Pathway: 510(k) (Special)
- Applicant: Venus Concept, Inc.
- Decided: Sep 11, 2023 after 49 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 275 ancestors in all.
No later device cites it as a predicate yet.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153717: Venus Versa System, Venus Concept, Ltd. (2016) Summary page 4.

## Indications for use
The Venus Versa PRO System is a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 IPL applicators are indicated for the following: • Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. • Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris. The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV. The Viva MD applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K232192
Methodology: https://510kreport.com/methodology