Cleared Traditional

K010495 - CENTURA PHOTOTHERAPY SPOTLIGHT (FDA 510(k) Clearance)

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

K010495 · Medical Illumination International, Inc. · General Hospital
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Mar 2001
Decision
17d
Days
Class 2
Risk

K010495 is an FDA 510(k) clearance for the CENTURA PHOTOTHERAPY SPOTLIGHT. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Medical Illumination International, Inc. (San Fernando, US). The FDA issued a Cleared decision on March 9, 2001 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - 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: 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 Medical Illumination International, Inc. devices

Submission Details

510(k) Number K010495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date March 09, 2001
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
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 - LBI Unit, Neonatal Phototherapy

All 70
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K010495.
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