Recall Z-0440-2021— Inova Lasers LLC

Name: FDA recall Z-0440-2021
Creator: U.S. Food and Drug Administration
Published: 2020-01-29

Class II · Ongoing

Class II FDA medical device recall by Inova Lasers LLC, initiated 2020-01-29. It names one FDA 510(k) clearance: K182604. Product: Class IV New Era medical laser device. 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..

Recalling firm: Inova Lasers LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-01-29
Firm location: New York, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K182604 — New EraStep UP Skin Laser, LLC·cleared 2018-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Class IV New Era medical laser device

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.