LZ30 LZ30-X
LZ30 LZ30-X 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 14 Jul 2021 (UDI-DI 00852116008018), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852116008018 | Date14 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123474 | Date3 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 00852116008018
- FDA 510(k) database K123474
Across registries
- FDA 510(k) K123474 decided 3 Dec 2013 Active
- FDA GUDID UDI-DI 00852116008018 listed 14 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K123474
- Listed FDA GUDID 00852116008018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LZ30
- Generic name
- Musculoskeletal/physical therapy laser, professional
- Model / reference
- LZ30-X
- Primary DI / UDI-DI
- 00852116008018
- 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
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