FDA.reportPublic FDA data

LZ30

Primary DI
00852116008063
Brand
LZ30
Company
AVANT WELLNESS SYSTEMS INC.
Model
LZ30-ProX
Device description
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
Published
2022-03-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K123474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123474000AVANT LASERAvant Wellness Systems, LLC2013-12-03ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852116008063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852116008063008521160080638521160080630852116008063

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-575-6569service@avantwellness.com

Regulatory Flags#

DUNS number
066550444
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852116008131LZ30LZ30 ReBl2025-08-27
00852116008148LZ30LZ30 GrVi2025-08-27
00852116008155LZ30LZ30 GrIR2025-08-27
00852116008162LZ30LZ30 GRIV2025-08-27
00852116008179LZ30LZ30 ProZ2025-04-29
00852116008186LZ30LZ30 Revi2025-04-29
00852116008193LZ30LZ30 MaxR2025-04-29
00852116008209LZ30LZ30 MaxIR2025-04-29
00852116008094LZ30LZ30 Z-Home2025-04-23
00852116008100LZ30LZ30 ProZ-Vet2025-04-23
00852116008124LZ30LZ30 Revi-Vet2025-04-23
00852116008117LZ30LZ30 Revi-Home2025-04-22
00852116008056LZ30LZ30-ProZ2022-03-03
00852116008087LZ30LZ30-Revi2022-03-03
00852116008032LZ30LZ30-ProR2022-03-03
00852116008049LZ30LZ30-ProIR2022-03-03
00852116008070LZ30LZ30-Home2022-03-03
00852116008001LZ30LZ30-Z2021-07-14
00852116008018LZ30LZ30-X2021-07-14
00852116008025LZ30LZ30-P2021-07-14

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Primary DI, Brand, Company table
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