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FDA 510(k)

D.O.R.C. SOLUX LIGHT SOURCE

K-Number: K973757 · 1997-11-07

ApplicantDutch Ophthalmic USA, Inc.
Decision Date1997-11-07
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

D.O.R.C. SOLUX LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 1997-11-07 under 510(k) number K973757. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D.O.R.C. SOLUX LIGHT SOURCE?

D.O.R.C. SOLUX LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K973757.

When did D.O.R.C. SOLUX LIGHT SOURCE receive FDA 510(k) clearance?

D.O.R.C. SOLUX LIGHT SOURCE received FDA 510(k) clearance on 1997-11-07, under 510(k) number K973757.

Who is the listed applicant for D.O.R.C. SOLUX LIGHT SOURCE?

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

What is the FDA product code for D.O.R.C. SOLUX LIGHT SOURCE?

The FDA product code for D.O.R.C. SOLUX LIGHT SOURCE is MPA.

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Other records listing Dutch Ophthalmic USA, 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.

K012821D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMK010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMK983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMK980636FIBER OPTIC ENDOILLUMINATION PROBEK973229D.O.R.C. HEXON ILLUMINATION SYSTEMK962135D.O.R.C. MICRODIATHERMY SYSTEM

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Related Devices (Code: MPA)

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.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

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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