FDA.reportPublic FDA data

Medical San

Primary DI
07898672790557
Brand
Medical San
Company
MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA
Model
Hakon Smart
Device description
The Dermatological Diode Laser (Model: Hakon Smart) is intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, long-term reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

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
K231901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231901000Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.2023-09-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898672790557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898672790557078986727905577898672790557

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826828108
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898672792193Medical SanLiftendo 2.02026-05-27
07898672790823Medical SanLiftendo2026-05-12
07898672790311Medical SanHakon2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16