FDA.reportPublic FDA data

Fraxis Duo Needle Handpiece

Primary DI
08800016903669
Brand
Fraxis Duo Needle Handpiece
Company
CLASSYS Inc.
Model
FRX-C2
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
GEXPowered Laser Surgical Instrument
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160312000FRAXIS DUOIlooda Co,., Ltd.2016-10-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023200041PreviousGS10
08800016903669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023200041088000232000418800023200041
08800016903669088000169036698800016903669

GMDN Terms#

Term, Definition table
TermDefinition
Intradermal radio-frequency ablation systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842183
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016904925Reepot Set PackageVSLS2024-10-30
08800016904932Reepot Main UnitVSLS2024-10-30
08800016904949Reepot HandpieceVSLS2024-10-30
08800016903140Max-25MAX-252025-07-02
08800016903171Max-M25MAX-M252025-07-02
08800016903423Max-25CMAX-25C2025-07-02
08800016903447Max-64CMAX-64C2025-07-02
08800016903454Max-M25CMAX-M25C2025-07-02
08800016904246MTR-AC-01MTR-AC-012025-07-02
08800016904253MTR-AC-04MTR-AC-042025-07-02
08800016904291MTR-AC-27GMTR-AC-27G2025-07-02
08800016905045QUADESSY Set PackageQD1-M4002025-07-02
08800016905052QUADESSY Main UnitQD1-M4002025-07-02
08800016905069QUADESSY Deeplus hand pieceQD1-M4002025-07-02
08800016905076QUADESSY Smartcure(Basic) hand pieceQD1-M4002025-07-02
08800016905083Wav12WAV122025-07-02
08800016905090Wav30WAV302025-07-02
08800016905106Wav50WAV502025-07-02
08800016905175QUADESSY Wavplus hand pieceQD1-M4002025-07-02
08800016905182QUADESSY Neutral hand pieceQD1-M4002025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21