Cleared Traditional

K970702 - SPECTRUM DESIGNS SPECTRAGEL

K970702 is an FDA 510(k) clearance for SPECTRUM DESIGNS SPECTRAGEL, manufactured by Spectrum Designs, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K970702 · Spectrum Designs, Inc. · General & Plastic Surgery device
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May 1997
Decision
75d
Days
Class 1
Risk

K970702 is an FDA 510(k) clearance for the SPECTRUM DESIGNS SPECTRAGEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spectrum Designs, Inc. devices

FDA 510(k) Submission Details - K970702

510(k) Number K970702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1997
Decision Date May 12, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 19
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K970702.
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · Pmt Corp. · Oct 1997
DEGANIA SILICONE SIL-K
K971482 · Degania Silicone , Ltd. · Jun 1997
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846 · Implantech Associates, Inc. · Feb 1997
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994