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FDA 510(k)

EPILATRON

K-Number: K810843 · 1981-05-08

ApplicantElectrola
Decision Date1981-05-08
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILATRON is the device name listed in this FDA 510(k) record. The listed applicant is Electrola. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K810843. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPILATRON?

EPILATRON is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Electrola. The 510(k) number is K810843.

When did EPILATRON receive FDA 510(k) clearance?

EPILATRON received FDA 510(k) clearance on 1981-05-08, under 510(k) number K810843.

Who is the listed applicant for EPILATRON?

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

What is the FDA product code for EPILATRON?

The FDA product code for EPILATRON is KCW.

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 Electrola 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.

K813181ELECTROC-GYMK811250ELECTRONIC MUSCLE STIMULATOR

Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943398THE BLENDTONE ROYALEInstantronK943396THE ELITE SPECTRUMInstantron

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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