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510(k) K070287

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 by Photonic Optische Gerate GmbH & Cokg — Product Code EBA

K070287 is an FDA 510(k) premarket notification submitted by Photonic Optische Gerate GmbH & Cokg for the device "PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500". The FDA issued a decision of Substantially Equivalent on February 12, 2007. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2007
Date Received
January 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical Headlight
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances for product code EBA

  • K923949 — SYLVAN DENTAL HEADLIGHT SYSTEM (October 16, 1992)
  • K893458 — FIBEROPTIC HEADLIGHT SYSTEM (June 22, 1989)
  • K854646 — VEGA DENTAL OPERATING LIGHT (March 6, 1986)
  • K842515 — SURGICAL HEADLIGHT (August 2, 1984)
  • K842358 — ISOLIGHT (July 31, 1984)
  • K822265 — FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (September 28, 1982)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K790807 — METALIT (August 3, 1979)
  • K790806 — PORCELIT (August 3, 1979)

FDA data resources