FDA.reportPublic FDA data

Positively Clear

Primary DI
B5863374
Brand
Positively Clear
Company
Tria Laser Inc
Model
BL2
Catalog number
3374
Published
2018-01-26
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
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160821000Tria SapphireTria Beauty, Inc.2016-06-15OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5863374PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blue-light phototherapy lamp, home-useA hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-321-8742customercare@triabeauty.com

Regulatory Flags#

DUNS number
116909762
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G7433426Smooth Beauty LaserSRL34262025-03-07
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
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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