# K253765: Vanish Pro

- Pathway: 510(k) (Traditional)
- Applicant: Ddc Technologies, Inc.
- Decided: Apr 22, 2026 after 148 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 28 generations back to K943450 (1995). 304 ancestors in all.
No later device cites it as a predicate yet.
0 of 305 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213569: HOLLYWOOD SPECTRA Laser System, Lutronic Corporation (2022) Summary page 6.
- K202503: Chrome, Quanta System Spa (2020) Summary page 6.

## Indications for use
The VANISH PRO is intended for the treatment of benign vascular lesions, benign pigmented lesions, and for tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of: 1064 nm in QS and PTM Modes: • Tattoo removal of black, brown, blue, and brown inks • Removal of benign pigmented lesions • Treatment of Melasma • Treatment of Nevus of Ota • Treatment of Common Nevi, Becker’s Nevi • Treatment of Café au Lait macules (CALMs) • Skin resurfacing procedures for the treatment of acne scars and wrinkles. 532 nm in QS and PTM Modes: • Tattoo removal of red, tan, purple, blue, yellow, and orange ink • Treatment of Café au Lait macules (CALMs) • Treatment of Lentigines • Removal of epidermal pigmented lesions • Removal of minor vascular lesions • Skin resurfacing procedures for the treatment of acne scars and wrinkles. • Treatment of seborrheic keratosis • Treatment of Freckles and Nevi Spilus • Treatment of post inflammatory hyperpigmentation

Source page: https://510kreport.com/device/K253765
Methodology: https://510kreport.com/methodology