Cleared Traditional

K080084 - CELL GEN LASER, MODEL CG-4000

K080084 is an FDA 510(k) clearance for CELL GEN LASER, manufactured by Cell Gen Therapeutics, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K080084 · Cell Gen Therapeutics, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
101d
Days
Class 2
Risk

K080084 is an FDA 510(k) clearance for the CELL GEN LASER, MODEL CG-4000. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Cell Gen Therapeutics, LLC (Dallas, US). The FDA issued a Cleared decision on April 21, 2008 after a review of 101 days - within the typical 510(k) review window.

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 - K080084

510(k) Number K080084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date April 21, 2008
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 116d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 222
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K080084.
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K080084 · CELL GEN LASER, MODEL CG-4000
Download PDF FDA Summary Cell Gen Therapeutics…