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510(k) K053364

HALUX IRIS EXAMINATION AND SURGICAL LAMP by Waldmann Lighting — Product Code FTD

K053364 is an FDA 510(k) premarket notification submitted by Waldmann Lighting for the device "HALUX IRIS EXAMINATION AND SURGICAL LAMP". The FDA issued a decision of Substantially Equivalent on February 23, 2006. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Waldmann Lighting has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2006
Date Received
December 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Waldmann Lighting

  • K841795 — UV 8001K, PUVA 800, PUVA 180/200 1000 (August 30, 1984)

Other clearances for product code FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)

FDA data resources