Cleared Traditional

K260427 - Lumicare (ONE)

Also marketed or referenced as:
Lumicare (ONE Lite) Lumicare (ONE+)

K260427 is an FDA 510(k) clearance for Lumicare (ONE), manufactured by Lumicare Medtech Co., Ltd.. The device is a Class 2 General Hospital device with product code SCS cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K260427 · Lumicare Medtech Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
261d
Days
Class 2
Risk

K260427 is an FDA 510(k) clearance for the Lumicare (ONE). Classified as Ultraviolet Radiation Disinfection Chamber Device (product code SCS), Class II - Special Controls.

Submitted by Lumicare Medtech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 29, 2026 after a review of 261 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6511 - 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.

FDA 510(k) Submission Details - K260427

510(k) Number K260427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2026
Decision Date October 29, 2026
Days to Decision 261 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SCS Device Classification - Class 2, Special Controls

Product Code SCS Ultraviolet Radiation Disinfection Chamber Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6511
Definition An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation.
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.

K260427 · Lumicare (ONE)
Download PDF FDA Summary Lumicare Medtech Co.,…