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FDA 510(k)

SOFTRANS INJECTOR

K-Number: K913626 · 1991-12-18

ApplicantStaar Surgical Co.
Decision Date1991-12-18
Product CodeHQL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFTRANS INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K913626. The device is classified under product code HQL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTRANS INJECTOR?

SOFTRANS INJECTOR is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Staar Surgical Co.. The 510(k) number is K913626.

When did SOFTRANS INJECTOR receive FDA 510(k) clearance?

SOFTRANS INJECTOR received FDA 510(k) clearance on 1991-12-18, under 510(k) number K913626.

Who is the listed applicant for SOFTRANS INJECTOR?

The FDA 510(k) record lists Staar Surgical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTRANS INJECTOR?

The FDA product code for SOFTRANS INJECTOR is HQL.

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Other records listing Staar Surgical Co. 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.

K090161EPIPHANY INJECTION SYSTEMK073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMK073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMK032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SK020734SURGE-FREE ASPIRATION ADAPTERK983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)

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Related Devices (Code: HQL)

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.

K914311CHIROFLEX II LENS MICROSERT(TM)Chiron OphthalmicsK842892NIDEK DIGITAL KERATOMETERNidek, Inc.K842504AMER. MEDICAL OPTICS DIGITAL KERATO-American Medical OpticsK771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens

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.

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