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510(k) K875042

ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY by Surgilase, Inc. — Product Code LKW

K875042 is an FDA 510(k) premarket notification submitted by Surgilase, Inc. for the device "ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY". The FDA issued a decision of Substantially Equivalent on June 24, 1988. The device falls under product code LKW (Laser, Neurosurgical), a Class III device. Surgilase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1988
Date Received
December 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Surgilase, Inc.

  • K932421 — SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE (October 15, 1993)
  • K924664 — SURGILASE FIBERLASE CO2 LASER WAVEGUIDE (April 15, 1993)
  • K905006 — SURGILASE SL 150 SURGICAL LASER SYSTEM (February 21, 1991)
  • K904203 — SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM (December 7, 1990)
  • K902211 — SURGILASE YAG 100 SURGICAL LASER SYSTEM (June 29, 1990)
  • K900570 — SURGILASE YAG 100 IN ORTHOPEDIC SURGERY (May 1, 1990)
  • K901227 — SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 (April 26, 1990)
  • K901211 — SURGILASE SL50 SURGICAL LASER SYSTEM (April 26, 1990)
  • K894471 — SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY (November 14, 1989)
  • K894396 — SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER (August 7, 1989)

Other clearances for product code LKW

  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)
  • K864166 — 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY (February 10, 1987)
  • K853580 — MEDILAS 2 (February 13, 1986)
  • K844440 — MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL (May 9, 1985)

FDA data resources