Cleared Traditional

K170215 - LaserDock

K170215 is an FDA 510(k) clearance for LaserDock, manufactured by Patient Pocket, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K170215 · Patient Pocket, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
85d
Days
Class 2
Risk

K170215 is an FDA 510(k) clearance for the LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock. 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 Patient Pocket, LLC (Cherry Hill, US). The FDA issued a Cleared decision on April 19, 2017 after a review of 85 days - a notably fast clearance cycle.

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: 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 Patient Pocket, LLC devices

FDA 510(k) Submission Details - K170215

510(k) Number K170215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date April 19, 2017
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 1681
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K170215.
SIROLaser Advance+
K170500 · Dentsply Sirona · May 2017
Venus Silk.expert
K170734 · Cyden Limited · May 2017
Cutera enlighten III Laser System
K170936 · Cutera, Inc. · Apr 2017
MultiPulse HoPLUS
K161257 · Asclepion Laser Technologies GmbH · Mar 2017
Cyber Ho
K170331 · Quanta System Spa · Mar 2017
Smart Laser Indirect Ophthalmoscope (LIO)
K162837 · Lumenis, Ltd. · Feb 2017