Cleared Traditional

K110735 - TANDA MAX OTC SYSTEM

K110735 is an FDA 510(k) clearance for TANDA MAX OTC SYSTEM, manufactured by Pharos Life Corporation. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K110735 · Pharos Life Corporation · General & Plastic Surgery device
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Aug 2011
Decision
140d
Days
Class 2
Risk

K110735 is an FDA 510(k) clearance for the TANDA MAX OTC SYSTEM. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Pharos Life Corporation (Washington, US). The FDA issued a Cleared decision on August 3, 2011 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K110735

510(k) Number K110735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date August 03, 2011
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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 General & Plastic Surgery devices follow this clearance model.