Cleared Traditional

K163655 - Sparkling

K163655 is an FDA 510(k) clearance for Sparkling, manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K163655 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
84d
Days
Class 2
Risk

K163655 is an FDA 510(k) clearance for the Sparkling. 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 Wonderful Opto-Electrics Tech.Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on March 17, 2017 after a review of 84 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 Wonderful Opto-Electrics Tech.Co.,Ltd devices

FDA 510(k) Submission Details - K163655

510(k) Number K163655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date March 17, 2017
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 1534
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K163655.
SIROLaser Advance+
K170500 · Dentsply Sirona · 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
Discovery Pico Family
K163222 · Quanta System Spa · Dec 2016