Product code FSO

Device name: Microscope, Surgical, General & Plastic Surgery
Medical specialty: General, Plastic Surgery
Device class: 1
Regulation number: 878.4700
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K942304	MICROFLEX	Moeller Microsurgical, Inc.	1994-06-13
K941399	OPERATING MICROSCOPE AA OM 10	Appasamy Associates (U.S.A.), Inc.	1994-04-22
K920689	DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM	Deemed, Inc.	1993-11-12
K926288	SOM 6VI (SURGICAL OPERATING MICROSCOPE)	Jedmed Instrument Co.	1993-10-12
K931303	WOODLYN OPERATION MICROSCOPE	Woodlyn, Inc.	1993-06-25
K926513	MOLLER-WEDEL OPERATING MICROSCOPE	Moeller Microsurgical, Inc.	1993-06-22
K910357	SOM 6V	Jedmed Instrument Co.	1991-02-19
K902076	J2 MICROSCOPE	Jedmed Instrument Co.	1990-08-01
K874241	OPMI MD SURGICAL MICROSCOPE	Carl Zeiss, Inc.	1987-12-23
K822562	ODONTO-SCOPE	Treace Medical, Inc.	1982-10-06
K822181	BINOCULAR OPER. MICROSCOPES & ACCESSOR	Kelleher Corp.	1982-08-27
K822015	BINOCULAR OPERATING MICROSCOPES AND	Kelleher Corp.	1982-07-30
K802713	FMS-02 FLOOR-UNIT MODEL MICROSCOPE	Jedmed Instrument Co.	1980-11-19
K801314	VOCON MODEL VC526	Teknar, Inc.	1980-09-09
K791280	OPERATION MICROSCOPE SOM 1	Elmed, Inc.	1979-07-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08906168451536	Prima Swift surgical Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451499	Prima Lite Surgical Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451505	Prima Lite Surgical Microscope Wall mount	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451512	Prima Lite ENT Surgical Microscopes	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451529	Prima Lite trainer	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451543	Prima Pro surgical Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451550	Prima Pro surgical Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08906168451567	Prima Floor Stand with Column	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2026-07-19
08908006463008	Labomed Prima ENT microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2023-06-14
08908006463015	Labomed Prima ENT microscope with Motorized fine focus	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2023-06-14
08908006463213	Labomed Prima Mu ENT microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2023-06-14
08908006463404	Labomed Magna Floor stand with Fluorescence Observation	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2023-06-13
08908006463244	Labomed Magna Ceiling mount (Long Arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2023-06-13
08908006463183	Labomed Magna Wall mount with motorized filter (Long arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-15
08908006463176	Labomed Magna Ceiling mount with motorized filter (Long arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-15
08908006463169	Labomed Magna Floor stand with motorized filter (Standard arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-15
08908006463152	Labomed Magna Wall mount (Long Arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-15
08908006463060	Labomed Prima DNT Microscope Table Mount	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463046	Labomed Prima DNT Microscope Wall mount	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463138	Labomed Magna Wall mount (Standard Arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463121	Labomed Magna Ceiling mount (Standard Arm)	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463114	Labomed Magna Floor stand standard arm Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463107	Labomed Prima DNT Microscope Floor Mount Fixed Long Arm	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463091	Labomed Prima DNT Microscope Floor Mount Fixed	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463084	Labomed Prima DNT Microscope Ceiling Mount Long Arm	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463077	Labomed Prima DNT Microscope Wall mount long arm	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463053	Labomed Prima DNT Microscope Ceiling Mount	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-13
08908006463206	Labomed Prima Mu DNT Microscope	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-12
08908006463022	Labomed Prima DNT Microscope Mobile Mount	LABOTECH MICROSCOPES INDIA PRIVATE LIMITED	2022-12-12
07630003525472	M844 Optics Carrier	Leica Microsystems (Schweiz) AG	2020-09-22

Product code FSO

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