510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070287Substantially Equivalent

Ps Series with Fiber Light Guide and Headlight, Models Ps200, Ps250, Ps500

Photonic Optische Gerate GmbH & Cokg, Vienna, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070287 is the FDA 510(k) clearance record for PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500, a class I device, cleared for Photonic Optische Gerate GmbH & Cokg on under FDA product code EBA (Light, Surgical Headlight). FDA records list one 510(k) clearance for Photonic Optische Gerate GmbH & Cokg. As of , FDA records show no recalls naming K070287.

Clearance record

Decision date
Received
(14 days to decision)
Product code
EBA Light, Surgical Headlight
Regulation
21 CFR 872.4630
Device class
Class I
Review panel
Dental
Applicant
Photonic Optische Gerate GmbH & Cokg Seebockgasse 59, Vienna, AT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EBA

Trailing 12 months

FDA records hold no clearances under product code EBA in the trailing twelve months.

FDA records show no clearances under product code EBA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260