Q Switched Nd: YAG Laser machine

Primary DI
06973011720103
Brand
Q Switched Nd: YAG Laser machine
Company
Sanhe LEFIS Electronics Co., Ltd
Model
LFS-C13U
Device description
The device comprises a main unit, light guide arm and footswitch.The working principle of Q Switched Nd: YAG Laser machine is that neodymium ions in neodymium doped yttrium aluminum garnet crystals are excited by the energy provided by the pump source and release photons. These photons are repeatedly reflected and stimulated to emit in the optical resonant cavity of the crystal, ultimately producing a specific wavelength (mainly 1064nm) and high energy density laser beam. It can also be converted from a 1064nm wavelength laser beam to a 532nm laser beam through frequency doubling technology; Then, it is effectively transmitted to the treatment site through the beam transmission device and plays a therapeutic role through the photothermal effect.
Published
2026-08-07
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
K252319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252319000Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.2025-10-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973011720103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973011720103069730117201036973011720103

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.

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
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06973011720158Intense Pulsed Light Therapy DeviceLFS-S6U2026-08-07
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06973011720028Diode Laser Therapy SystemLFS-K52020-04-28
06973011720035Diode Laser Therapy SystemLFS-K22020-04-28

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