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FDA 510(k)

CLASSIC 70 LENS

K-Number: K871649 · 1987-05-29

ApplicantKorea Asahi Optical Co., Ltd.
Decision Date1987-05-29
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLASSIC 70 LENS is the device name listed in this FDA 510(k) record. The listed applicant is Korea Asahi Optical Co., Ltd.. It received FDA 510(k) clearance on 1987-05-29 under 510(k) number K871649. 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 CLASSIC 70 LENS?

CLASSIC 70 LENS is a medical device that received FDA 510(k) clearance on 1987-05-29. The listed applicant is Korea Asahi Optical Co., Ltd.. The 510(k) number is K871649.

When did CLASSIC 70 LENS receive FDA 510(k) clearance?

CLASSIC 70 LENS received FDA 510(k) clearance on 1987-05-29, under 510(k) number K871649.

Who is the listed applicant for CLASSIC 70 LENS?

The FDA 510(k) record lists Korea Asahi Optical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLASSIC 70 LENS?

The FDA product code for CLASSIC 70 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Korea Asahi Optical Co., Ltd. as applicant

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.

K871961MULTIPLE SPECTACLE LENS

Related Devices (Code: HQC)

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.

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 LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 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

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

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