Intense Pulsed Light Therapy Device

Primary DI
06973011720158
Brand
Intense Pulsed Light Therapy Device
Company
Sanhe LEFIS Electronics Co., Ltd
Model
LFS-S6U
Device description
The device comprises a main unit, handpiece, filter, and footswitch.The working principle of Intense Pulsed Light Therapy Device (IPL) is that the trigger applies a high voltage to a specific substance in the light source to trigger its ionization. After the energy storage capacitor is charged for a relatively long time, it discharges in an extremely short time, causing the avalanche ionization of the specific substance in the light source. This specific substance converts and releases the charged electrical energy in the form of high-intensity light radiation, and this discharging process is a light pulse. A filter can be used to remove the undesired emission spectrum, forming a multi-band light output to achieve different intended purposes.
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
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261204000Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.2026-06-12ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973011720158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973011720158069730117201586973011720158

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

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
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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