FDA.reportPublic FDA data

Smooth Beauty Laser

Primary DI
G7433426
Brand
Smooth Beauty Laser
Company
Tria Laser Inc
Model
SRL
Catalog number
3426
Device description
TRIA FRX
Published
2025-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130459000TRIA FAN SYSTEMTria Beauty, Inc.2013-10-25ONG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G7433426PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological laser beam guiding handpieceA hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
925-783-0217reden.salcedo@thebeautytechgroup.com

Regulatory Flags#

DUNS number
116909762
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G7433724HAIR REMOVAL LASERHRL 4X37242025-03-07
B58613752Skin Renu LaserSRL137522020-07-13
B5863159HAIR REMOVAL LASERHRL 4X31592020-07-13
B5863192HAIR REMOVAL LASERHRL 4X31922020-07-13
B5863386Positively Clear Acne Clearing Blue LightBL233862020-07-13
B5863634Hair Removal Laser PrecisisonHRLp36342020-07-13
B5863725HAIR REMOVAL LASERHRL 4X37252020-07-13
B5863174HAIR REMOVAL LASERHRL 4X31742017-09-08
B5863175HAIR REMOVAL LASERHRL 4X31752017-09-08
B5863178HAIR REMOVAL LASERHRL 4X31782017-09-08
B5863271HAIR REMOVAL LASERHRL 4X32712017-10-06
B5863374Positively ClearBL233742018-01-26
B5863426Smooth Beauty LaserSRL34262017-12-06
B5863503Smooth Beauty Eye Wrinkle LaserFANp35032018-01-26
B5863600Hair Removal Laser PrecisisonHRLp36002017-10-13
B5863724HAIR REMOVAL LASERHRL 4X37242018-06-20

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Primary DI, Brand, Company table
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06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.ONG2025-09-17
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08057622080004MTONE EVOM & T SRLONG2025-04-15
08057622080011MTONE EVOM & T SRLONG2025-04-15
08057622080028MT ONEM & T SRLONG2025-04-15
08057622080035MT ONEM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONG2025-04-15
08800016903959Fraxis Set PackageCLASSYS Inc.ONG2024-10-30
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