Cleared Traditional

BLUESHINE'S GOLD SERIES (K110375) - FDA 510(k) Clearance

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

K110375 · Blueshine Srl · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
379d
Days
Class 2
Risk

K110375 is an FDA 510(k) clearance for the BLUESHINE'S GOLD SERIES. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Blueshine Srl (Mestre(Ve), IT). The FDA issued a Cleared decision on February 23, 2012 after a review of 379 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 Blueshine Srl devices

Submission Details

510(k) Number K110375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2011
Decision Date February 23, 2012
Days to Decision 379 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
264d slower than avg
Panel avg: 115d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition For The Temporary Increase Of Clear Nail In Patients With Onychomycosis (e.g., Dermatophytes Trichophyton Rubrum And T Mentagrophytes, And/or Yeasts Candida Albicans, Etc.).
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 - PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

All 18
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K110375.
Medicell Mycosis Laser (MCML24004)
K253960 · Medicell Healthcare Co.,LTD · Mar 2026
Onycho Laser V
K241116 · Terasysd&C, Inc. · Jul 2024
TFX-LT2000 Therapy Light
K211265 · Toefx, Inc. · Nov 2022
AF Laser
K221363 · ShenB Co., Ltd. · Jul 2022
REMY Medical Therapy Laser System
K190034 · Footdocprenur, LLC · May 2019