Manufacturer
Ddc Technologies, Inc.VANISH PRO
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253765
- Device name
- VANISH PRO
- Company
- Ddc Technologies, Inc.
- 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—
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Not ingested
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Not ingested
Chrome
HOLLYWOOD SPECTRA Laser System
K253765 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253765 as a predicate