Manufacturer
Shangdong Huamei Technology Co., Ltd.Nd: YAG Laser Therapy Systems HM-YL900
Shangdong Huamei 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
- K202758
- Device name
- Nd: YAG Laser Therapy Systems HM-YL900
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-09-21
- Decision date
- 2020-11-16
- 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 Nd: YAG Laser Therapy Systems 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: • 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
Intended Use
The Nd: YAG Laser Therapy Systems 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: 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 Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel - The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters setting and accurate control of the output laser energy by the operator. Main Control Module - The module uses the microcontroller as the heart, receives the laser energy parameters and work command from the control panel and detects the state of footswitch and interlock switch; Controls the work state of laser RF power supply; Uploads the alarm information of footswitch and interlock switch during system working. Auxiliary Control Module - The module is mainly composed of bi-color indicator and super-quiet adjustable air pump and other components; its working state is determined by the command from the main control module to meet the device requirements, and independently monitor the DC power module output. Laser, laser RF power supply and DC power supply module - The module completes the YAG laser emission according to the command from the control panel. Light arm module - The light arm module is the output part of the device, which consists of a socket for light arm, a light arm, the joint for light arm, a hard film reflector and a focusing lens and a handpiece.
Summary parsed at:2026-06-01 05:48:42 UTC
Predicate devices
3—
—
Not ingested
—
—
Not ingested
Q-Switched Nd: YAG Laser System
K202758 references 3 predicate/reference devices
Cited as predicate
3Nd:Yag Laser Therapy Systems
Q-Switched Nd:Yag laser (K690)
Nd: YAG Laser Therapy Systems
3 submissions cite K202758 as a predicate
