COMMANDER MARK II HAIR REMOVAL SYSTEM— 510(k) K943872

Name: FDA 510(k) clearance K943872
Creator: U.S. Food and Drug Administration
Published: 1995-10-26

Substantially Equivalent

The Helene Edgar Corp.

FDA 510(k) clearance K943872 for COMMANDER MARK II HAIR REMOVAL SYSTEM, Substantially Equivalent on 1995-10-26. Applicant: The Helene Edgar Corp.. Device class: 1.

Clearance details

Applicant: The Helene Edgar Corp.
Product code: Code KCX
Device class: Class 1
Regulation: 21 CFR 878.5360
Advisory panel: General, Plastic Surgery
Date received: 1994-08-08
Decision date: 1995-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guelph, Ontario, CA

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Recent devices under product code KCX

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K973773 — DAPELLE HAIR REMOVER1997-12-17
K973340 — TWEEZER-TYPE EPILATOR1997-12-03
K973174 — SONIQUE HAIR REMOVER1997-10-30
K973179 — FEMINIQUE SONIC HAIR REMOVER1997-10-30
K972695 — FINALLY FREE1997-10-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.