Submission Details
| 510(k) Number | K070287 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
Feb 2007
Decision
14d
Days
Class 1
Risk
About This 510(k) Submission
K070287 is an FDA 510(k) clearance for the PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Photonic Optische Gerate GmbH & Cokg (Vienna, AT). The FDA issued a Cleared decision on February 12, 2007, 14 days after receiving the submission on January 29, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.
Device Classification
| Product Code | EBA — Light, Surgical Headlight |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4630 |
Manufacturer
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