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FSP

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Loupe, Diagnostic/Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
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RecordFirmDate
IMS5000 ILLUMINATED LOUPES (K895248)Luxtec Corp.1989-09-15
SURGICAL LOUPES (K891895)Zinnanti Surgical Instruments, Inc.1989-04-12
LUXTEC LOUPES FOR SURGICAL VISION (K864386)Luxtec Corp.1986-11-17
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (K861749)Keeler Instruments, Inc.1986-05-23

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Every clearance here is in the API, with alerts when new ones post.