Cleared Traditional

K932930 - CANDELA MINIBRUSH

K932930 is the FDA 510(k) clearance for CANDELA MINIBRUSH by Candela Laser Corp.. It is a Class 2 General Hospital device (product code FEB) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K932930 · Candela Laser Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
112d
Days
Class 2
Risk

K932930 is an FDA 510(k) clearance for the CANDELA MINIBRUSH. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on October 5, 1993 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Candela Laser Corp. devices

Submission Details

510(k) Number K932930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1993
Decision Date October 05, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Hospital devices follow this clearance model.

Regulatory Peers - FEB Accessories, Cleaning, For Endoscope

All 25
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K932930.
EW-10 AND EW-20
K915402 · Olympus Corp. · Jun 1995
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · United States Surgical, A Division of Tyco Healthc · Sep 1994
FLUID PUMP, CP #3
K914524 · United States Endoscopy Group, Inc. · Mar 1994
FLEXIBLE URETERONEPHROSOCOPE
K924135 · Applied Medical Resources · Apr 1993
CLEANING BRUSH
K924103 · United States Endoscopy Group, Inc. · Nov 1992