FDA 510(k)

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

K-Number: K925254 · 1993-01-07

Decision Date1993-01-07

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 is the device name listed in this FDA 510(k) record. The listed applicant is Allergan Medical Optics. It received FDA 510(k) clearance on 1993-01-07 under 510(k) number K925254. 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 AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38?

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 is a medical device that received FDA 510(k) clearance on 1993-01-07. The listed applicant is Allergan Medical Optics. The 510(k) number is K925254.

When did AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 receive FDA 510(k) clearance?

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 received FDA 510(k) clearance on 1993-01-07, under 510(k) number K925254.

Who is the listed applicant for AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38?

The FDA 510(k) record lists Allergan Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38?

The FDA product code for AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 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 Allergan Medical Optics as applicant

K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM K941603AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE K930320AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR K924235AMO ELITE K911998MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR

View all 7 devices →

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.