Cleared Traditional

K073022 - CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830

K073022 is an FDA 510(k) clearance for CLAREBLEND LED PROBES MODEL# 7201-415, manufactured by Clareblend, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K073022 · Clareblend, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
341d
Days
Class 2
Risk

K073022 is an FDA 510(k) clearance for the CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Clareblend, Inc. (Elgin, US). The FDA issued a Cleared decision on October 1, 2008 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Clareblend, Inc. devices

FDA 510(k) Submission Details - K073022

510(k) Number K073022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2007
Decision Date October 01, 2008
Days to Decision 341 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
226d slower than avg
Panel avg: 115d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
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. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. 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 - GEX Powered Laser Surgical Instrument

All 2381
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K073022.
POWERLIPO LASER SYSTEM
K082096 · Lutronic Corporation · Oct 2008
EVIS MD PLATINUM RED LIGHT THERAPY
K082247 · Ageless Beauty Corporation · Oct 2008
LUMAPROBE
K073000 · Clareblend, Inc. · Oct 2008
SMOOTHKIT+
K082004 · Osyris · Sep 2008
SELLAS
K080382 · Dinona Co., Ltd. · Sep 2008
MATRIX RF APPLICATOR
K073572 · Syneron Medical, Ltd. · Sep 2008