RecallRadar

FDA Device recall Z-0768-2020

LightPod ERA lasers

On 2020-01-15 the FDA classified a Class II recall of LightPod ERA lasers by Aerolase, citing this relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0768-2020
ClassificationClass II
Statusterminated
Initiated2019-08-01
Published2020-01-15
Last updated2026-09-13 11:55 UTC
CompanyAerolase
DistributionUS

Product

LightPod ERA lasers

Reason

This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device

Identifiers

code_infoLightPod ERA Lasers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0768-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.