Diode Laser Therapy System

Primary DI
06973011720134
Brand
Diode Laser Therapy System
Company
Sanhe LEFIS Electronics Co., Ltd
Model
LFS-K13
Device description
The basic working principle of diode laser hair removal instrument is based on biological effect. This product adopts the laser with the 808nm wavelength for irradiation, which are particularly sensitive to the melanocyte of hair follicle with no damage to normal epidermis. The light can be absorbed by the melanin in the hair shaft and hair follicles and is transformed into heat, thus increase the hair follicle temperature, when the temperature rose to a higher extent, the irreversible damage can be produced to the structure of hair follicle, thus, the damaged hair follicles can be removed after a natural physiological process, so as to achieve the purpose of permanent hair removal.
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261562000Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.2026-09-10GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973011720134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973011720134069730117201346973011720134

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA 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.

Regulatory Flags#

DUNS number
550747317
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973011720080CO2 Laser Therapy SystemLFS-D9U2026-08-07
06973011720103Q Switched Nd: YAG Laser machineLFS-C13U2026-08-07
06973011720158Intense Pulsed Light Therapy DeviceLFS-S6U2026-08-07
06973011720011Diode Laser Therapy SystemLFS-K82020-04-28
06973011720028Diode Laser Therapy SystemLFS-K52020-04-28
06973011720035Diode Laser Therapy SystemLFS-K22020-04-28

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