Cleared Traditional

ZenPro 40 (K230268) - FDA 510(k) Clearance

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

K230268 · BLUECORE COMPANY Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
191d
Days
Class 2
Risk

K230268 is an FDA 510(k) clearance for the ZenPro 40. 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 BLUECORE COMPANY Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on August 10, 2023 after a review of 191 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 BLUECORE COMPANY Co., Ltd. devices

Submission Details

510(k) Number K230268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date August 10, 2023
Days to Decision 191 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
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

Bio-Med USA, Inc.
Young Chi

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 536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K230268.
Holmium Medical Laser
K231718 · Allengers Global Healthcare Private Limited · Aug 2023
Phototherapy System (OL-PDT950)
K230342 · Shanghai Omni Laser Skinology Co., Ltd. · Aug 2023
V-Laser
K231054 · Wontech Co., Ltd. · Aug 2023
Medical Diode Laser, Model S1Pro
K231548 · Wuhan Pioon Technology Co., Ltd. · Aug 2023
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
K222862 · Lotuxs Medtech (Suzhou) Co., Ltd. · Jul 2023
VenaCure EVLT NeverTouch Procedure Kits
K231945 · AngioDynamics, Inc. · Jul 2023