THE ELITE SPECTRUM— 510(k) K943396

Substantially Equivalent

Instantron

FDA 510(k) clearance K943396 for THE ELITE SPECTRUM, Substantially Equivalent on 1994-09-16. Applicant: Instantron. Device class: 1.

Clearance details

Applicant: Instantron
Product code: Code KCW
Device class: Class 1
Regulation: 21 CFR 878.5350
Advisory panel: General, Plastic Surgery
Date received: 1994-07-14
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Providence, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCW

K954031 — COMPU-BLEND EPILATOR1996-01-05
K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION1995-10-18
K943928 — APILUS ELECTROPIL1995-01-12
K945192 — HAIR REMOVAL SYSTEM1995-01-12
K943398 — THE BLENDTONE ROYALE1994-09-16

More clearances from Instantron

K943399 — THE SS-991994-09-16
K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL1994-08-18
K931062 — THE VP500 EPILATOR1993-07-08
K931063 — THE ELITE EPILATOR1993-07-08
K931064 — THE BLENDTONE EPILATOR1993-07-08

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