Vevazz LCD

Primary DI
B552VEVAZZLCD0
Brand
Vevazz LCD
Company
VEVAZZ LLC
Model
Vevazz LCD
Device description
The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
Published
2017-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162763000Vevazz LED Heat LampVevazz, LLC2017-01-05ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B552VEVAZZLCD0PrimaryHIBCC0

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
047229225
Device count
1
Serial number
true
Manufacturing date on label
true

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