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510(k) K881499

SURGILASE YAG 100 FOR GYNECOLOGY USE by Surgilase, Inc. — Product Code LLO

K881499 is an FDA 510(k) premarket notification submitted by Surgilase, Inc. for the device "SURGILASE YAG 100 FOR GYNECOLOGY USE". The FDA issued a decision of Substantially Equivalent on April 29, 1988. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Surgilase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1988
Date Received
March 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Pulmonary Surgery
Device Class
Class II
Regulation Number
874.4500
Review Panel
AN
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)
  • K901211 — SURGILASE SL50 SURGICAL LASER SYSTEM (April 26, 1990)
  • K901227 — SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 (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 LLO

  • K884815 — SLT CLMD CONTACT LASER (December 22, 1988)
  • K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (April 25, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (February 2, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K872351 — FIBERLASE II ND:YAG LASER FOR PULMONARY USE (December 11, 1987)
  • K870505 — OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL (August 7, 1987)
  • K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (July 21, 1987)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources