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510(k) K810117

HALOGEN HEADLIGHT SYSTEM by Colmed, Ltd. — Product Code EBA

K810117 is an FDA 510(k) premarket notification submitted by Colmed, Ltd. for the device "HALOGEN HEADLIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 10, 1981. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630. Colmed, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1981
Date Received
January 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Colmed, Ltd.

  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K810636 — VARIODRAIN (May 1, 1981)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT (May 14, 1980)
  • K792241 — PELIMIT (November 30, 1979)

Other clearances for product code EBA

  • K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (February 12, 2007)
  • 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)
  • K790807 — METALIT (August 3, 1979)
  • K790806 — PORCELIT (August 3, 1979)

FDA data resources