Q-Switched Nd: YAG Laser System

Shanghai Apolo Medical Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K190936
Device name
Q-Switched Nd: YAG Laser System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-04-10
Decision date
2019-06-17
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength (nominal delivered energy of 585nm and 650nm with optional dye handpiece):
• Removal of light ink (red, sky blue, green, purple, and orange) tattoo
• Treatment of benign vascular lesions including, but not limited to: telangiectasias,
• Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becker's, nevi, freckles, Nevus spilus, Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation
1064nm wavelength:
• Removal dark ink (black, blue and brown) tattoo
• Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
The SPECTRA Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedure for coagulation and hemostasis.
532nm Wavelength (normal delivered energy of 585nm and 650nm with optional dye handpieces):
• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigment Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Treatment of Lentigines
• Treatment of Café-Au-lait
• Treatment of Post Inflammatory Hyper-Pigmentation
• Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
• Tattoo removal: dark ink (black, blue and brown)
• Removal of Epidermal Pigment Lesions
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Common Nevi
• Treatment of melasma.

Intended Use

The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength (nominal delivered energy of 585nm and 650nm with optional dye handpiece): Removal of light ink (red, sky blue, green, purple, and orange) tattoo, Treatment of benign vascular lesions including, but not limited to: telangiectasias, Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses, Treatment of Post Inflammatory Hyper-Pigmentation. 1064nm wavelength: Removal dark ink (black, blue and brown) tattoo, Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, Removal or lightening of unwanted hair with or without adjuvant preparation, Skin resurfacing procedures for the treatment of acne scars and wrinkles.

Device Description

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system, foot switch and others accessories. The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532nm wavelength to 585nm and 650nm. The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

Summary parsed at:2026-06-01 05:55:14 UTC

Predicate devices

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K190936 references 1 predicate/reference device

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