FDA Medical Device Recalls (openFDA)
Inova Lasers LLC: Class IV New Era medical laser device
- Recall number
- Z-0440-2021
- Recalling firm
- Inova Lasers LLC
- Product
- Class IV New Era medical laser device
- Status
- Open, Classified
- Initiated
- 2020-01-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- New Era laser units
- 510(k) numbers
- ["K182604"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3015191149
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28