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LZ30 LZ30-ProIR

by Avant Wellness Systems Inc

LZ30 LZ30-ProIR is a Class II device made by Avant Wellness Systems Inc, cleared under FDA 510(k) K123474 on 3 Dec 2013 and listed in FDA GUDID since 3 Mar 2022 (UDI-DI 00852116008049), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K123474

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852116008049 UDI-DI Date3 Mar 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK123474 Date3 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123474 decided 3 Dec 2013 Active
  • FDA GUDID UDI-DI 00852116008049 listed 3 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123474
  2. Listed FDA GUDID 00852116008049

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LZ30
Generic name
Musculoskeletal/physical therapy laser, professional
Model / reference
LZ30-ProIR
Primary DI / UDI-DI
00852116008049
510(k) Number
FDA product code
ILY
GMDN term
Musculoskeletal/physical therapy laser, professional
Device class
Class II
Regulation number
890.5500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K123474)

and 8 more cleared under K123474

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

Other devices from Avant Wellness Systems Inc

  • LZ30 LZ30 MaxR

    Class II

  • LZ30 LZ30 MaxIR

    Class II

  • LZ30 LZ30 GrIR

    Class II

  • LZ30 LZ30 ProZ-Vet

    Class II

See all devices from Avant Wellness Systems Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)