VANISH PRO

Ddc Technologies, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253765
Device name
VANISH PRO
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-11-25
Decision date
2026-04-22
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentAcne treatment
Primary application
Pigment treatment
Classification source
AI classified

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

Intended 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

Device Description

The VANISH PRO is an aesthetic laser system designed and manufactured by DOC Technologies, Inc. The VANISH PRO emits Q-Switched, 1064nm pulses intended for tattoo removal and other indications for use. The VANISH PRO is designed to be pumped and operated by a solid-state Alexandrite laser, primarily the POLYLASE aesthetic laser systems (K040055 and K010715).

Summary parsed at:2026-06-01 05:18:50 UTC

Predicate devices

4

K253765 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K253765 as a predicate