Cleared Traditional

K070287 - PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500

K070287 is an FDA 510(k) clearance for PS SERIES WITH FIBER LIGHT GUIDE AND HE..., manufactured by Photonic Optische Gerate GmbH & Cokg. The device is a Class 1 Dental device with product code EBA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K070287 · Photonic Optische Gerate GmbH & Cokg · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
14d
Days
Class 1
Risk

K070287 is an FDA 510(k) clearance for the PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Photonic Optische Gerate GmbH & Cokg (Vienna, AT). The FDA issued a Cleared decision on February 12, 2007 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - the FDA dental device regulatory 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 - K070287

510(k) Number K070287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date February 12, 2007
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
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
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EBA Device Classification - Class 1, General Controls

Product Code EBA Light, Surgical Headlight
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Tuv Sud America, Inc.
STEFAN PREISS

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 - EBA Light, Surgical Headlight

All 9
Devices cleared under the same product code (EBA) and FDA review panel - the closest regulatory comparables to K070287.
SYLVAN DENTAL HEADLIGHT SYSTEM
K923949 · Sylvan Medical Fiberoptics · Oct 1992
FIBEROPTIC HEADLIGHT SYSTEM
K893458 · Cuda Products Co. · Jun 1989
VEGA DENTAL OPERATING LIGHT
K854646 · Alpine Dental Equipment Co. · Mar 1986
SURGICAL HEADLIGHT
K842515 · Good-Lite Co. · Aug 1984
ISOLIGHT
K842358 · Planmeca USA, Inc. · Jul 1984
FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
K822265 · Kelleher Corp. · Sep 1982
K070287 · PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
Download PDF FDA Summary Photonic Optische Ger…