Cleared Traditional

K070270 - PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36

K070270 is an FDA 510(k) clearance for PICCOLIGHT E50, manufactured by Kirchner & Wilhelm GmbH + Co.Kg. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K070270 · Kirchner & Wilhelm GmbH + Co.Kg · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
280d
Days
Class 2
Risk

K070270 is an FDA 510(k) clearance for the PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Kirchner & Wilhelm GmbH + Co.Kg (Great Neck, US). The FDA issued a Cleared decision on November 5, 2007 after a review of 280 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K070270

510(k) Number K070270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date November 05, 2007
Days to Decision 280 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 110d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 40
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K070270.
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K131719 · Medical Devices (Pvt) , Ltd. · Oct 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587 · Heine Optotechnik GmbH & Co. KG · Mar 2013
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · American Diagnostic Corp. · Nov 2010
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
K052599 · Suzhou 66 Vision-Tech Co., Ltd. · Nov 2006
OPTYSE OPHTHALMOSCOPE
K061278 · Ophthalmos , Ltd. · May 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · Precision Optics Corp. · Jan 2006
K070270 · PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
Download PDF FDA Summary Kirchner & Wilhelm Gm…