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FDA 510(k)

OCULOSTAT

K-Number: K981235 · 1998-07-15

ApplicantLaser Center Dev. Corp.
Decision Date1998-07-15
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULOSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Laser Center Dev. Corp.. It received FDA 510(k) clearance on 1998-07-15 under 510(k) number K981235. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULOSTAT?

OCULOSTAT is a medical device that received FDA 510(k) clearance on 1998-07-15. The listed applicant is Laser Center Dev. Corp.. The 510(k) number is K981235.

When did OCULOSTAT receive FDA 510(k) clearance?

OCULOSTAT received FDA 510(k) clearance on 1998-07-15, under 510(k) number K981235.

Who is the listed applicant for OCULOSTAT?

The FDA 510(k) record lists Laser Center Dev. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCULOSTAT?

The FDA product code for OCULOSTAT is HNC.

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 Laser Center Dev. 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.

K981063AUTOMATED CORNEAL TREPHINE

Related Devices (Code: HNC)

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.

K022836STEPHENS DISPOSABLE SPECULUMStephens InstrumentsK964289EYE FIXATION SPECULUMEyefix, Inc.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.K843196VISITEC EYE SPECULUMVisitec Co.K830430EYELID SPECULUMDouglas C. Mckee & Co.

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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