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Bioptron AG

FDA Regulatory Profile

Bioptron AG has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Bioptron AG" and its spelling variant "Bioptron".

Latest inspection: Nov 2, 2017 · VAI
Latest 510(k): Feb 4, 2004

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	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

Recent FDA Inspections

2 inspections from Nov 1, 2017 to Nov 2, 2017.

Date	Site	Product	Classification	FEI
Nov 2, 2017	Wollerau, Switzerland	Devices	Voluntary Action Indicated (VAI)	3003775404
Nov 1, 2017	Neuchatel, Switzerland	Devices	Voluntary Action Indicated (VAI)	3013929417

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003775404	Wollerau, Switzerland	1	Nov 2, 2017
FEI 3013929417	Neuchatel, Switzerland	1	Nov 1, 2017

Recent 510(k) Clearances

1 510(k) clearance on Feb 4, 2004.

K-Number	Device	Date
K032216	BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM	Feb 4, 2004

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