Q-Switched Nd:YAG Laser System

Ami, Inc.

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
K172908
Device name
Q-Switched Nd:YAG Laser System
Company
Ami, Inc.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-09-25
Decision date
2017-12-07
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Skin resurfacingPigment treatmentHair removalSurgical cutting
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The Q-MASTER 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 benign pigmented and benign 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 benign vascular lesions including, but not limited to:
  - port wine birthmarks
  - telangiectasias
  - spider angioma
  - cherry angioma
  - spider nevus
- Treatment of benign 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 Q-MASTER 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 benign pigmented and benign 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 benign vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevus - Treatment of benign 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.

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

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