Cleared Traditional

K072097 - BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1

K072097 is an FDA 510(k) clearance for BILIBEE LED PHOTOTHERAPY SYSTEM, manufactured by Medical Select, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K072097 · Medical Select, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
91d
Days
Class 2
Risk

K072097 is an FDA 510(k) clearance for the BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Medical Select, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 30, 2007 after a review of 91 days - within the typical 510(k) review window.

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: 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 - K072097

510(k) Number K072097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date October 30, 2007
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K072097.
BILI-MIRROR MODEL BLM-1
K093618 · Physician Engineered Products, Inc. · Apr 2010
BILI BLUE F20T12/BBY AND F40T12/BBY
K090192 · Interlectric Corp. · Apr 2009
MEDILED PHOTOTHERAPY LAMP
K083179 · Medix I.C.S.A. · Feb 2009
LULLABY
K071828 · Ge Healthcare Clinical Systems · Aug 2007
WALLABY 4
K070180 · Respironics Inc., Sleep & Home Respiratory Group · May 2007
BILISOFT PHOTOTHERAPY SYSTEM
K053568 · Lumitex, Inc. · Apr 2006
K072097 · BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
Download PDF FDA Summary Medical Select, Inc.