Pastelle

Wontech Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250165
Device name
Pastelle
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-01-21
Decision date
2025-07-03
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingPigment treatmentHair removalSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:
- Tattoo removal: dark ink (black, blue, and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma

1064nm in Genesis (long-pulse) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyperpigmentation
- Treatment of Becker's Nevi, Freckles, and Nevi spilus

Intended Use

The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma 1064nm in Genesis (long-pulse) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of Lentigines - Treatment of Café-au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and Nevi spilus

Device Description

The Pastelle laser system consists of an Nd:YAG laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains two Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed in the special adjustable holders composed the laser cavity.

Summary parsed at:2026-06-01 05:22:10 UTC

Predicate devices

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