Mira, Inc.

Waltham, MA, US

Mira, Inc. appears in FDA device records in Waltham, MA. FDA records list 19 510(k) clearances between 1984-11-06 and 1997-03-19, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 19
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 19 510(k) clearances for Mira, Inc. between 1984 and 1997. The busiest year on record is 1986, with 10. The most recent is 1997, with 1.

Clearances by year, as a table

510(k) clearance decisions for Mira, Inc., by decision year
Year	Clearances
1984	1
1985	2
1986	10
1989	2
1990	1
1992	1
1994	1
1997	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K951728	SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE	HLI	Substantially Equivalent	1997-03-19
K933527	MODIFICATION OF ANTERIOR SEGMENT ELECTRODES	HWA	Substantially Equivalent	1994-01-25
K923629	OPHTHALMIC TRICHIASIS PROBE	HPS	Substantially Equivalent	1992-10-19
K894248	CONVERTER SYSTEM	HQE	Substantially Equivalent	1990-02-27
K891601	POWER OPERATED AND CONTROLLED VITREOUS SCISSORS	HQE	Substantially Equivalent	1989-05-23
K890448	LIGHT SOURCE, ENDOSCOP, XENON ARC	FFS	Substantially Equivalent	1989-05-08
K863246	MIRALITE	HQF	Substantially Equivalent	1986-10-31
K863591	ENDOPHOTOCOAGULATION PROBE	HQF	Substantially Equivalent	1986-10-10
K855105	SIMMONS SHELL	HQT	Substantially Equivalent	1986-03-31
K854869	INTRAOCULAR FORCEPS & SCISSORS	HNR	Substantially Equivalent	1986-03-05
K855215	AIR/FLUID EXCHANGE SYSTEM	FRN	Substantially Equivalent	1986-02-27
K854870	INTRAOCULAR ELECTROMAGNET	HPO	Substantially Equivalent	1986-02-19
K854872	VFI/VFE SYSTEM II		Substantially Equivalent	1986-02-13
K854871	MICRO SURGICAL SYSTEM	HQE	Substantially Equivalent	1986-02-07
K854868	I/A - VFE SYSTEM II	HQE	Substantially Equivalent	1986-02-07
K854873	INTRAOCULAR PRESSURE REDUCER	LCR	Substantially Equivalent	1986-02-04
K854288	OPHALMIC LASER PHOTOCOAGULATOR	HQF	Substantially Equivalent	1985-11-12
K853890	OPHTHALMIC LASER PHOTOCOAGULATOR	HQF	Substantially Equivalent	1985-11-12
K843345	AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON		Substantially Equivalent	1984-11-06

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain