Diode Laser Hair Removal Machine · GLD01
Sanhe Meditech Co.Ltd
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- false
- Commercial distribution status
- In Commercial Distribution
- Public device record key
- 09b1ba81-2a2e-499b-8eb2-7a91de0834b9
- Has serial number
- true
- Public version date
- 2026-05-21
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 443657496
- Is labeled as no nrl
- false
- Is single use
- false
- Is otc
- false
- Version or model number
- GLD01
- Has manufacturing date
- true
- Brand name
- Diode Laser Hair Removal Machine
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Company name
- Sanhe Meditech Co.Ltd
- Public version status
- New
- Has expiration date
- false
- Is hct p
- false
- Publish date
- 2026-05-13
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 06978716980012
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- GEX
- Name
- Powered Laser Surgical Instrument
- Harmonized identifiers (openFDA)
- Device name
- Powered Laser Surgical Instrument
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4810
- Device class
- 2
- Premarket submissions
- Submission number
- K252427
- Supplement number
- 000
- Gmdn terms
- Code
- 58786
- Name
- Dermatological diode laser system
- Implantable
- false
- Code status
- Active
- Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.