Cleared Traditional

CO2 Laser Therapy System (K201109) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201109 · Shanghai Apolo Medical Technology Co., Ltd. · General & Plastic Surgery device
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Jul 2020
Decision
79d
Days
Class 2
Risk

K201109 is an FDA 510(k) clearance for the CO2 Laser Therapy System. 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 Shanghai Apolo Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 15, 2020 after a review of 79 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 Shanghai Apolo Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K201109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date July 15, 2020
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Shanghai Landlink Medical Information Technology Co., Ltd.
Shelley Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 532
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K201109.
NeuroBlate System
K201056 · Monteris Medical, Inc. · Aug 2020
Picowon
K201406 · Wontech Co., Ltd. · Jul 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
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K201455 · Quanta System Spa · Jun 2020
Stardust Med
K200736 · I.T.S. Group S.R.L. · Jun 2020
Nd: YAG Laser Therapy Systems
K193477 · Beijing Kes Biology Technology Co., Ltd. · Jun 2020