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FDA 510(k)

AUTOMATED CORNEAL TREPHINE

K-Number: K981063 · 1998-06-23

ApplicantLaser Center Dev. Corp.
Decision Date1998-06-23
Product CodeHRG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATED CORNEAL TREPHINE 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 1998-06-23 under 510(k) number K981063. The device is classified under product code HRG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED CORNEAL TREPHINE?

AUTOMATED CORNEAL TREPHINE is a medical device that received FDA 510(k) clearance on 1998-06-23. The listed applicant is Laser Center Dev. Corp.. The 510(k) number is K981063.

When did AUTOMATED CORNEAL TREPHINE receive FDA 510(k) clearance?

AUTOMATED CORNEAL TREPHINE received FDA 510(k) clearance on 1998-06-23, under 510(k) number K981063.

Who is the listed applicant for AUTOMATED CORNEAL TREPHINE?

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 AUTOMATED CORNEAL TREPHINE?

The FDA product code for AUTOMATED CORNEAL TREPHINE is HRG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K981235OCULOSTAT

Related Devices (Code: HRG)

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.

K013151ASMOTOM AUTOMATED TREPHINE SYSTEMBkg Opthalmics USA, Inc.K843957ULTRATHIN/SP LENSOptical Systems Intl., Inc.K841515SCANLAN VASCU-STATT IIScanlan Intl., Inc.K823901TREPHINE BLADES-VARIOUS MODELSEdward Weck, Inc.K791763(MICRO-KERATRON, MICRO DUCT TREPHINE)Intl. Ophthalmic Industries Corp.

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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