Cleared Traditional

K042165 - CUTERA TABLETOP AESTHETIC PRODUCT

K042165 is the FDA 510(k) clearance for CUTERA TABLETOP AESTHETIC PRODUCT by Cutera, Inc.. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K042165 · Cutera, Inc. · Physical Medicine device
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Oct 2004
Decision
68d
Days
Class 2
Risk

K042165 is an FDA 510(k) clearance for the CUTERA TABLETOP AESTHETIC PRODUCT. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on October 18, 2004 after a review of 68 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.

View all Cutera, Inc. devices

Submission Details

510(k) Number K042165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2004
Decision Date October 18, 2004
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 16
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K042165.
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537 · Cynosure, Inc. · Sep 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005
RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · Rich-Mar Corp. · May 2004
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 2003
OLYMPIC WARM-UP
K001056 · Olympic Medical Corp. · Sep 2000