FDA.reportPublic FDA data

LZ30

Primary DI
00852116008209
Brand
LZ30
Company
AVANT WELLNESS SYSTEMS INC.
Model
LZ30 MaxIR
Device description
Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
Published
2025-04-29
Public version status
New
Distribution status
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
00852116008209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852116008209008521160082098521160082090852116008209

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), improvement of local 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 intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

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
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
00852116008063LZ30LZ30-ProX2022-03-03
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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00810140063014RENPHOJoicom CorporationILY2026-05-08
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.ILY2026-05-03
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B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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G180DIOWAVESTEALTHMAX0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-11-12
G180DIOWAVE50WLS0DiowaveTECHNOLOGICAL MEDICAL ADVANCEMENTS L.L.C.ILY2025-10-31
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