FDA.reportPublic FDA data

SurgiLight 1470 Diode Laser System

Primary DI
06976712970235
Brand
SurgiLight 1470 Diode Laser System
Company
Micro-Energy Medical Technology Co., Ltd
Model
Halo
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K251049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251049000SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.2025-07-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976712970235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976712970235069767129702356976712970235

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
620289544
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976712970297Hemolase FiberHemo-R-0.40-2.52026-07-13
06976712970303Hemolase FiberHemo-R-0.60-2.52026-07-13
06976712970310Hemolase FiberHemo-R-0.40-1.82026-07-13
06976712970327Hemolase FiberHemo-R-0.60-1.82026-07-13
06976712970334Hemo NeedleHemo-0012026-07-13
06976712970341Hemo Luer LockHemo-0022026-07-13
06976712970242Halo Sterile Single-use Radial FiberHalo-R-0.40-2.52025-12-20
06976712970259Halo Sterile Single-use Radial FiberHalo-R-0.60-2.52025-12-20
06976712970266Halo Sterile Single-use Radial FiberNovo-R-0.40-1.82025-12-20
06976712970273Halo Sterile Single-use Radial FiberNovo-R-0.60-1.82025-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
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08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
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06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16