FDA.reportPublic FDA data

LaserTouchOne

Primary DI
00869340000305
Brand
LaserTouchOne
Company
Laser Health Technologies, LLC
Model
1
Published
2017-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100116000LASERTOUCHONE (OTC)Laser Health Technologies, LLC2010-04-15NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869340000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869340000305008693400003058693400003050869340000305

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, home-useAn electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a healthcare provider in both a clinical setting and in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
799028142
Device count
1
Serial number
true
Manufacturing date on label
true

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