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FDA 510(k)

EPITRON SUPER

K-Number: K834572 · 1984-04-23

ApplicantLeo Unlimited, Inc.
Decision Date1984-04-23
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPITRON SUPER is the device name listed in this FDA 510(k) record. The listed applicant is Leo Unlimited, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K834572. 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 EPITRON SUPER?

EPITRON SUPER is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Leo Unlimited, Inc.. The 510(k) number is K834572.

When did EPITRON SUPER receive FDA 510(k) clearance?

EPITRON SUPER received FDA 510(k) clearance on 1984-04-23, under 510(k) number K834572.

Who is the listed applicant for EPITRON SUPER?

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

What is the FDA product code for EPITRON SUPER?

The FDA product code for EPITRON SUPER 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.

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Other records listing Leo Unlimited, 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.

K833946EPILOT 80 S TMK833945COSMODYN-S INTERFERENTIAL MUSCLE STIM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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