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510(k) K842515

SURGICAL HEADLIGHT by Good-Lite Co. — Product Code EBA

K842515 is an FDA 510(k) premarket notification submitted by Good-Lite Co. for the device "SURGICAL HEADLIGHT". The FDA issued a decision of Substantially Equivalent on August 2, 1984. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630. Good-Lite Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1984
Date Received
June 12, 1984
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 Good-Lite Co.

  • K842135 — HI-LO FLOOR STANDING EXAM. LIGHT (July 6, 1984)
  • K833956 — DOT VISUAL ACVITY TEST 2000 (January 4, 1984)

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)
  • K842358 — ISOLIGHT (July 31, 1984)
  • K822265 — FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (September 28, 1982)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K790806 — PORCELIT (August 3, 1979)
  • K790807 — METALIT (August 3, 1979)

FDA data resources