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Inova Lasers LLC

FDA Regulatory Profile

Inova Lasers LLC has 1 FDA recall, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Inova Lasers LLC" and its spelling variant "Inova Lasers".

Latest recall: Z-0440-2021 · Class II · Jan 29, 2020
Latest inspection: Sep 17, 2021 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Inova Lasers LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Recall records
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	1	0	0
2020	1	1	1
2019	0	0	0
2018	0	0	0
2017	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

1 recall record on Jan 29, 2020.

Number	Class	Product	Date
Z-0440-2021	Class II	Class IV New Era medical laser device	Jan 29, 2020

Recent FDA inspections

2 inspections from Feb 7, 2020 to Sep 17, 2021.

Date	Site	Product	Classification	FEI
Sep 17, 2021	New York, NY	Devices	Voluntary Action Indicated (VAI)	3015191149
Feb 7, 2020	New York, NY	Devices	Official Action Indicated (OAI)	3015191149

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3015191149	New York, NY	2	Sep 17, 2021

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