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

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

3

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

K202758 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K202758 as a predicate