Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.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
Product code
GEX
21 CFR 878.4810
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
1—
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Not ingested
K190936 references 1 predicate/reference device
Cited as predicate
1Nd: YAG Laser Therapy Systems HM-YL900
1 submission cite K190936 as a predicate
