Cleared Traditional

K071180 - SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

K071180 is an FDA 510(k) clearance for SCINTILLANT SURGICAL LIGHT, manufactured by Engineered Medical Solutions Co., LLC. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K071180 · Engineered Medical Solutions Co., LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
51d
Days
Class 2
Risk

K071180 is an FDA 510(k) clearance for the SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Engineered Medical Solutions Co., LLC (Leola, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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.

FDA 510(k) Submission Details - K071180

510(k) Number K071180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date June 20, 2007
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FTD Device Classification - Class 2, Special Controls

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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

Kema Quality B.V.
PATRICIA L MURPHY

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 - FTD Lamp, Surgical

All 25
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K071180.
ATRICURE DISSECTOR
K111020 · AtriCure, Inc. · Jun 2011
HM-LAMP II
K100234 · Hillusa, Inc. · Jul 2010
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
HALUX IRIS EXAMINATION AND SURGICAL LAMP
K053364 · Waldmann Lighting · Feb 2006
ATRICURE DISSECTOR
K041681 · AtriCure, Inc. · Jul 2004
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001

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.

K071180 · SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
Download PDF FDA Summary Engineered Medical So…