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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 116d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

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FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K090008 · TANDA RESTORE, MODEL PTSCS
Download PDF FDA Summary Pharos Life Corporati…