FDA.reportPublic FDA data

LED Spectrum therapy instrument

Primary DI
06976264730066
Brand
LED Spectrum therapy instrument
Company
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD
Model
PDT-M
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K231894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231894000LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.2023-09-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976264730066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976264730066069762647300666976264730066

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
706040997
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976264730028LED Spectrum therapy instrumentPDT-I2023-11-17
06976264730035LED Spectrum therapy instrumentPDT-J2023-11-17
06976264730042LED Spectrum therapy instrumentPDT-K2023-11-17
06976264730059LED Spectrum therapy instrumentPDT-L2023-11-17
06976264730073Radio Frequency SystemRF-3012023-11-17
06976264730080Microneedle electrodes25-Pin2023-11-17
06976264730097Microneedle electrodes49-Pin2023-11-17
06976264730103RF electrodes49-RF2023-11-17

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00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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