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FDA 510(k)

EPILATOR, MULTIPLE NEEDLE-MODEL EM-20

K-Number: K811501 · 1981-07-10

ApplicantRcx-Western, Inc.
Decision Date1981-07-10
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 is the device name listed in this FDA 510(k) record. The listed applicant is Rcx-Western, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811501. 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 EPILATOR, MULTIPLE NEEDLE-MODEL EM-20?

EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Rcx-Western, Inc.. The 510(k) number is K811501.

When did EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 receive FDA 510(k) clearance?

EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811501.

Who is the listed applicant for EPILATOR, MULTIPLE NEEDLE-MODEL EM-20?

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

What is the FDA product code for EPILATOR, MULTIPLE NEEDLE-MODEL EM-20?

The FDA product code for EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 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 Rcx-Western, 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.

K811502STIMULATOR, FACIAL-MODELS SF-100 & 200K811503EPILATOR, BLEND-MODEL EB-200 & ET-1

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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