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510(k) K954263

XE-LITE by Ophthalmic Technologies, Inc. — Product Code FTD

K954263 is an FDA 510(k) premarket notification submitted by Ophthalmic Technologies, Inc. for the device "XE-LITE". The FDA issued a decision of Substantially Equivalent (with conditions) on October 18, 1995. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Ophthalmic Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 18, 1995
Date Received
September 12, 1995
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 Ophthalmic Technologies, Inc.

  • K042885 — OCT-OPTHALMOSCOPE (January 21, 2005)
  • K031391 — HF MODULE WITH TRANSDUCERS (June 20, 2003)
  • K030770 — OTI SCAN WITH TRANSDUCERS (March 27, 2003)
  • K024114 — A-SCAN 100 (January 10, 2003)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K974522 — 3D I-SCAN (February 25, 1998)
  • K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE (June 25, 1997)
  • K960622 — I-SCAN (May 13, 1996)

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)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)

FDA data resources