FDA 510(k)

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

K-Number: K894512 · 1989-10-17

ApplicantIntl. Ophthalmic Industries Corp.

Decision Date1989-10-17

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Ophthalmic Industries Corp.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K894512. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS?

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Intl. Ophthalmic Industries Corp.. The 510(k) number is K894512.

When did PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS receive FDA 510(k) clearance?

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS received FDA 510(k) clearance on 1989-10-17, under 510(k) number K894512.

Who is the listed applicant for PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS?

The FDA 510(k) record lists Intl. Ophthalmic Industries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS?

The FDA product code for PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS is HQC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intl. Ophthalmic Industries Corp. as applicant

K961658MEGATRON OPHTHALMIC SURGICAL SYSTEM K894513DIATHRON(R) DIATHERMY UNIT K894511MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT K823088ASPITRON K791763(MICRO-KERATRON, MICRO DUCT TREPHINE)

Related Devices (Code: HQC)

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.