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FDA 510(k)

DROLITE(TM) LIGHT SOURCE

K-Number: K913273 · 1991-12-04

ApplicantVision Medical, Inc.
Decision Date1991-12-04
Product CodeHJM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DROLITE(TM) LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Vision Medical, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K913273. The device is classified under product code HJM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DROLITE(TM) LIGHT SOURCE?

DROLITE(TM) LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Vision Medical, Inc.. The 510(k) number is K913273.

When did DROLITE(TM) LIGHT SOURCE receive FDA 510(k) clearance?

DROLITE(TM) LIGHT SOURCE received FDA 510(k) clearance on 1991-12-04, under 510(k) number K913273.

Who is the listed applicant for DROLITE(TM) LIGHT SOURCE?

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

What is the FDA product code for DROLITE(TM) LIGHT SOURCE?

The FDA product code for DROLITE(TM) LIGHT SOURCE is HJM.

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.

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Other records listing Vision Medical, Inc. 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.

K913837MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM

Related Devices (Code: HJM)

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.

K972506INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORInfinitech, Inc.K950529PEREGRINE DIFFUSION LIGHT PIPEPeregrine Surgical , Ltd.K945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHTWells Johnson Co.K931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEHgm, Inc.K933445DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)Storz Instrument Co.K940393PEREGRINE WIDE ANGLE LIGHT PIPEPeregrine Surgical , Ltd.

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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