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FDA 510(k)

MODIFICATION TO: VELSCOPE

K-Number: K070523 · 2007-04-05

ApplicantLed Dental, Inc.
Decision Date2007-04-05
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VELSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Led Dental, Inc.. It received FDA 510(k) clearance on 2007-04-05 under 510(k) number K070523. The device is classified under product code NXV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: VELSCOPE?

MODIFICATION TO: VELSCOPE is a medical device that received FDA 510(k) clearance on 2007-04-05. The listed applicant is Led Dental, Inc.. The 510(k) number is K070523.

When did MODIFICATION TO: VELSCOPE receive FDA 510(k) clearance?

MODIFICATION TO: VELSCOPE received FDA 510(k) clearance on 2007-04-05, under 510(k) number K070523.

Who is the listed applicant for MODIFICATION TO: VELSCOPE?

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

What is the FDA product code for MODIFICATION TO: VELSCOPE?

The FDA product code for MODIFICATION TO: VELSCOPE is NXV.

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 Led Dental, 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.

K153710Tuxedo Digital Dental SensorK102083VELSCOPE VX

Related Devices (Code: NXV)

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.

K123169ORALIDForward Science, LLCK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.K102083VELSCOPE VXLed Dental, Inc.K101140DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.K090135TRIMIRA IDENTAFI 3000Remicalm, LLCK082668BIO-SCREENAddent, Inc.

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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