Cleared Traditional

K101490 - FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL

K101490 is an FDA 510(k) clearance for FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, manufactured by Thermage, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K101490 · Thermage, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
99d
Days
Class 2
Risk

K101490 is an FDA 510(k) clearance for the FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Thermage, Inc. (Hayward, US). The FDA issued a Cleared decision on September 8, 2010 after a review of 99 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.

View all Thermage, Inc. devices

FDA 510(k) Submission Details - K101490

510(k) Number K101490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2010
Decision Date September 08, 2010
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONG Device Classification - Class 2, Special Controls

Product Code ONG Powered Laser Surgical Instrument With Microbeamfractional Output
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. Indication For Use Can Be General And/or Specific. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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.

Regulatory Peers - ONG Powered Laser Surgical Instrument With Microbeamfractional Output

All 20
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K101490.
EMERGE FRACTIONAL LASER
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LOI SYSTEM
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