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510(k) K013511

XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) by Aculux, Inc. — Product Code FSW

K013511 is an FDA 510(k) premarket notification submitted by Aculux, Inc. for the device "XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)". The FDA issued a decision of Substantially Equivalent on February 1, 2002. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. Aculux, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2002
Date Received
October 22, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Aculux, Inc.

  • K001223 — ACULUX, MODEL AX3001, AX3002 (June 23, 2000)

Other clearances for product code FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources