Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MENTOR TONO-PEN 3

K-Number: K964312 · 1996-11-26

ApplicantMentor Ophthalmics, Inc.
Decision Date1996-11-26
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR TONO-PEN 3 is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Ophthalmics, Inc.. It received FDA 510(k) clearance on 1996-11-26 under 510(k) number K964312. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR TONO-PEN 3?

MENTOR TONO-PEN 3 is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Mentor Ophthalmics, Inc.. The 510(k) number is K964312.

When did MENTOR TONO-PEN 3 receive FDA 510(k) clearance?

MENTOR TONO-PEN 3 received FDA 510(k) clearance on 1996-11-26, under 510(k) number K964312.

Who is the listed applicant for MENTOR TONO-PEN 3?

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

What is the FDA product code for MENTOR TONO-PEN 3?

The FDA product code for MENTOR TONO-PEN 3 is HKY.

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 Mentor Ophthalmics, 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.

K973146MENTOR SUPER ABSORBENT DRAPEK971538MENTOR GEMINI HEMOSTATIC ERASERK960765MENTOR ADVENT A/B SYSTEM

Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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.

↑