Manufacturer
Ids, LimitedQ-Switched Nd:YAG Laser System
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K171079
- Device name
- Q-Switched Nd:YAG Laser System
- Company
- Ids, Limited
- 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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