Cleared Traditional

K093624 - OPTISCAN MODEL OPTISCAN CEIS

K093624 is an FDA 510(k) clearance for OPTISCAN MODEL OPTISCAN CEIS, manufactured by Optiscan Pty. , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K093624 · Optiscan Pty. , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
102d
Days
Class 2
Risk

K093624 is an FDA 510(k) clearance for the OPTISCAN MODEL OPTISCAN CEIS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Optiscan Pty. , Ltd. (Notting Hill Vic, AU). The FDA issued a Cleared decision on March 5, 2010 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Optiscan Pty. , Ltd. devices

FDA 510(k) Submission Details - K093624

510(k) Number K093624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date March 05, 2010
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 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 & Plastic Surgery devices follow this clearance model.

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