Cleared Traditional

K042740 - ISC-1000 PENTAX CONFOCAL LASER SYSTEM

K042740 is an FDA 510(k) clearance for ISC-1000 PENTAX CONFOCAL LASER SYSTEM, manufactured by Pentax Medical Company. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K042740 · Pentax Medical Company · General & Plastic Surgery device
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Oct 2004
Decision
15d
Days
Class 2
Risk

K042740 is an FDA 510(k) clearance for the ISC-1000 PENTAX CONFOCAL LASER SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Pentax Medical Company (Montvale, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 15 days - a notably fast clearance cycle.

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: 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 Pentax Medical Company devices

FDA 510(k) Submission Details - K042740

510(k) Number K042740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date October 19, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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.

Regulatory Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 - GCJ Laparoscope, General & Plastic Surgery

All 1131
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K042740.
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EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
K042741 · Pentax Medical Company · Oct 2004
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K042412 · United States Surgical, A Division of Tyco Healthc · Sep 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · Applied Medical Resources Corp. · Sep 2004

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.