Cleared Traditional

K090008 - TANDA RESTORE, MODEL PTSCS

K090008 is an FDA 510(k) clearance for TANDA RESTORE, manufactured by Pharos Life Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K090008 · Pharos Life Corporation · Physical Medicine device
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Oct 2009
Decision
286d
Days
Class 2
Risk

K090008 is an FDA 510(k) clearance for the TANDA RESTORE, MODEL PTSCS. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Pharos Life Corporation (Cambridge, CA). The FDA issued a Cleared decision on October 15, 2009 after a review of 286 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharos Life Corporation devices

FDA 510(k) Submission Details - K090008

510(k) Number K090008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date October 15, 2009
Days to Decision 286 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 115d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 34
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