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FDA 510(k)

ASPITRON

K-Number: K823088 · 1983-04-06

ApplicantIntl. Ophthalmic Industries Corp.
Decision Date1983-04-06
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ASPITRON 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 1983-04-06 under 510(k) number K823088. 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 ASPITRON?

ASPITRON is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Intl. Ophthalmic Industries Corp.. The 510(k) number is K823088.

When did ASPITRON receive FDA 510(k) clearance?

ASPITRON received FDA 510(k) clearance on 1983-04-06, under 510(k) number K823088.

Who is the listed applicant for ASPITRON?

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 ASPITRON?

The FDA product code for ASPITRON is HQC.

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Other records listing Intl. Ophthalmic Industries Corp. 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.

K961658MEGATRON OPHTHALMIC SURGICAL SYSTEMK894513DIATHRON(R) DIATHERMY UNITK894512PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENSK894511MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNITK791763(MICRO-KERATRON, MICRO DUCT TREPHINE)

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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