Cleared Traditional

K082707 - MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER

K082707 is an FDA 510(k) clearance for MEDX LPT 200 TETHERED LASER & MEDX LPS ..., manufactured by Medx Electronics, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K082707 · Medx Electronics, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
15d
Days
Class 2
Risk

K082707 is an FDA 510(k) clearance for the MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Medx Electronics, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on October 1, 2008 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082707

510(k) Number K082707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date October 01, 2008
Days to Decision 15 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
101d faster than avg
Panel avg: 116d · This submission: 15d
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

Intertek Testing Services
DANIEL W LEHTONEN

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

All 222
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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.

K082707 · MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
Download PDF FDA Summary Medx Electronics, Inc.