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Precise Optics

FDA Regulatory Profile

Precise Optics has 0 FDA recalls, 2 inspections, 13 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 25, 2013 · NAI
Latest 510(k)
Apr 7, 2003

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances13Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 25, 2013Bay Shore, NYDevicesNo Action Indicated (NAI)2429479
May 24, 2011Bay Shore, NYDevicesNo Action Indicated (NAI)2429479

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 2429479Bay Shore, NY2Apr 25, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMApr 7, 2003
K935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERMar 16, 1994
K932878PRECISION INTRA-ORAL SCOPESJan 6, 1994
K914084ENDOSCOPESJan 22, 1992
K914184P2020-8-0 BEAM-LIMITING DEVICENov 27, 1991
K911744PRECISION OPTICS CORPORATION LAPAROSCOPEJul 26, 1991
K903459PRECISION OPTICS ENDOSCOPE ADAPTEROct 26, 1990
K903457PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)Oct 19, 1990
K903458PRECISION OPTICS IMAGE COUPLEROct 19, 1990
K827087P1808 MOBILE C-ARM IMAGE INTENSIFIERMar 4, 1982
K820178PI808 MOBILE C-ARM IMAGE INTENSIFIERMar 4, 1982
K792307DENTIX DENTAL X-RAY UNITJan 9, 1980
K792225P1806 MOBILE C-ARM IMAGE INTENSIFIERDec 20, 1979

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.