Z-0440-2021Class II

Class IV New Era medical laser device

Name: Z-0440-2021 Class IV New Era medical laser device
Creator: Inova Lasers LLC
Published: 2020-01-29
License: https://open.fda.gov/license/

Inova Lasers LLC / initiated 2020-01-29 / Open, Classified

FDA source

Inova Lasers LLC began a recall of Class IV New Era medical laser device on 2020-01-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0440-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-01-29
Posted: 2020-11-17
Recalling firm: Inova Lasers LLC
Product: Class IV New Era medical laser device
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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.
FDA 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 in commerce: 8 units
Distribution: US Nationwide Distribution
Product codes and lots: New Era laser units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0440-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0440-2021	Class II	Ongoing	FDA Mandated	2020-11-25	2020-11-17

Product code GEX

K182604Class IINew EraStep UP Skin Laser, LLC / cleared 2018-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)