FDA.reportPublic FDA data

QUADESSY Deeplus hand piece

Primary DI
08800016905069
Brand
QUADESSY Deeplus hand piece
Company
CLASSYS Inc.
Model
QD1-M400
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241157000Secret MAX Multi-platform RF SystemIlooda Co,., Ltd.2024-11-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016905069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016905069088000169050698800016905069

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842183
Device count
1
Kit
true
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
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
08800016902945VOLNEWMERVM1-M1202024-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016814675EndyMed Intensif 10 pack tips package ENDYMED MEDICAL LTDOUH2026-05-07
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2025-11-17
08800016903140Max-25CLASSYS Inc.OUH2025-07-02
08800016903171Max-M25CLASSYS Inc.OUH2025-07-02
08800016903423Max-25CCLASSYS Inc.OUH2025-07-02
08800016903447Max-64CCLASSYS Inc.OUH2025-07-02
08800016903454Max-M25CCLASSYS Inc.OUH2025-07-02
08800016905045QUADESSY Set PackageCLASSYS Inc.OUH2025-07-02
08800016905052QUADESSY Main UnitCLASSYS Inc.OUH2025-07-02
07290016814668PURE DentAENDYMED MEDICAL LTDOUH2024-11-06
08800016903683Secret PRO Set PackageCLASSYS Inc.OUH2024-10-31
08800016903690Secret PRO Main UnitCLASSYS Inc.OUH2024-10-31
08800016903706Secret PRO Articulated ArmCLASSYS Inc.OUH2024-10-31
08800016903713Secret PRO Scanner HandpieceCLASSYS Inc.OUH2024-10-31
08800016903720Secret PRO Needle HanpdieceCLASSYS Inc.OUH2024-10-31
08800016903737Secret PRO Bigger HandpieceCLASSYS Inc.OUH2024-10-31
08800016903744Secret PRO Smartcure HandpieceCLASSYS Inc.OUH2024-10-31
08800016903195Fraxis Duo 25Pin Needle TipCLASSYS Inc.OUH2024-10-30
08800016903294Secret RF Main UnitCLASSYS Inc.OUH2024-10-30
08800016903300Secret RF Bigger HandpieceCLASSYS Inc.OUH2024-10-30
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.OUH2024-10-30
08800016903331Secret RF Small HandpieceCLASSYS Inc.OUH2024-10-30
08800016903621Fraxis DUO Set PackageCLASSYS Inc.OUH2024-10-30
08800016903638Fraxis Duo Main UnitCLASSYS Inc.OUH2024-10-30
08800016903645Fraxis Duo Articulated armCLASSYS Inc.OUH2024-10-30
08800016903652Fraxis Duo Scanner HandpieceCLASSYS Inc.OUH2024-10-30
08800016903669Fraxis Duo Needle HandpieceCLASSYS Inc.OUH2024-10-30
08800016903287Secret RF Set PackageCLASSYS Inc.OUH2024-10-25
07290016814408EndyMed PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2024-05-16
07290016814422EndyMed PRO MAX, Small MAX HandpieceENDYMED MEDICAL LTDOUH2024-05-16