Cleared Traditional

K070250 - NUTRITONE FACIAL BEAUTY SYSTEM

K070250 is an FDA 510(k) clearance for NUTRITONE FACIAL BEAUTY SYSTEM, manufactured by Isomers Laboratories, Inc.. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 587-day FDA review.

K070250 · Isomers Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
587d
Days
Class 2
Risk

K070250 is an FDA 510(k) clearance for the NUTRITONE FACIAL BEAUTY SYSTEM. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Isomers Laboratories, Inc. (Montgomery Village,, US). The FDA issued a Cleared decision on September 4, 2008 after a review of 587 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K070250

510(k) Number K070250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2007
Decision Date September 04, 2008
Days to Decision 587 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
438d slower than avg
Panel avg: 149d · This submission: 587d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 80
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K070250.
BMR FACE
K103031 · Bio-Medical Research, Ltd. · Nov 2011
NUFACE PLUS
K103472 · Carol Cole Company · Nov 2011
RUGALIFT, MODEL# V.2.1
K071573 · Fatrotek S.R.L. · Dec 2008
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
K070217 · Neuro Resource Group, Inc. · Apr 2008
NUFACE, MODEL NU-4003
K072260 · Carol Cole Company · Nov 2007
FACEMASTER FACIAL TONING SYSTEM
K040871 · Facemaster of Beverly Hills, Inc. · Jun 2005
K070250 · NUTRITONE FACIAL BEAUTY SYSTEM
Download PDF FDA Summary Isomers Laboratories,…