Q-Switched Nd:YAG Laser System

Ids, Limited

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

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Device details

FDA 510(k) registration fields

K number
K171079
Device name
Q-Switched Nd:YAG Laser System
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-04-11
Decision date
2017-08-01
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Pigment treatmentHair removalSkin resurfacingSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Q10 Q-Switched Nd:YAG Laser System is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

- Removal of dark ink (black, blue and brown) tattoos
- Treatment of nevus of Ota
- Treatment of common nevus
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

- Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650nm with the optional 585nm and 650nm dye hand-piece):

- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- Treatment of vascular lesions including, but not limited to:
  - port wine birthmarks
  - telangiectasias
  - spider angioma
  - cherry angioma
  - spider nevus
- Treatment of pigmented lesions including, but not limited to:
  - café-au-lait birthmarks
  - solar lentigines
  - senile lentigines
  - Becker's nevus
  - freckles
  - common nevus
  - nevus spilus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles

Intended Use

The Q10 Q-Switched Nd:YAG Laser System is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology. 1064nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevus - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064nm wavelength in non Q-switched mode: - Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris. 532nm wavelength in Q-switched mode: - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevus - Treatment of pigmented lesions including, but not limited to: café-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevus, freckles, common nevus, nevus spilus - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles.

Device Description

The Q10 Q-Switched Nd:YAG Laser System is a laser device that operates at a wavelength of 1064nm in Q-switched and non Q-switched modes, and 532nm in Q-switched mode with optional dye hand-pieces. It is designed for various dermatological applications including tattoo removal, treatment of pigmented and vascular lesions, hair removal, and skin resurfacing procedures.

Summary parsed at:2026-06-01 06:00:10 UTC

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