← Back to catalogue

Lz30

FDA UDI

Class II (US FDA UDI)

by Avant Wellness Systems Inc

Identity

Trade Name
LZ30 FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, professional FDA UDI
Device Name
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes. FDA UDI
Model / Reference
LZ30-ProX FDA UDI
Description
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes. FDA UDI

Identifiers

Primary DI / UDI-DI
00852116008063 FDA UDI
510(k) Number
K123474 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Lz30 by Avant Wellness Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K123474 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Avant Wellness Systems Inc

Sources (1)

  • FDA UDI 7522e059-48f5-4c2b-bd27-ddd6855dc9a2 36 fields · synced May 30, 2026