FDA.reportPublic FDA data

LZ30

Primary DI
00852116008193
Brand
LZ30
Company
AVANT WELLNESS SYSTEMS INC.
Model
LZ30 MaxR
Device description
Portable, battery powered laser therapy device emitting up to 2W at 635nm 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
00852116008193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852116008193008521160081938521160081930852116008193

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
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
00852116008063LZ30LZ30-ProX2022-03-03
00852116008070LZ30LZ30-Home2022-03-03
00852116008001LZ30LZ30-Z2021-07-14
00852116008018LZ30LZ30-X2021-07-14
00852116008025LZ30LZ30-P2021-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08