Home / 510(k) Clearances / K861045

510(k) K861045

MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT by Sharplan Industries, Inc. — Product Code LLO

K861045 is an FDA 510(k) premarket notification submitted by Sharplan Industries, Inc. for the device "MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Sharplan Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 18, 1986
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 Sharplan Industries, Inc.

  • K861044 — MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND (October 28, 1986)
  • K861047 — MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL (June 17, 1986)
  • K861046 — MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA (May 2, 1986)

Other clearances for product code LLO

  • K884815 — SLT CLMD CONTACT LASER (December 22, 1988)
  • K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USE (April 29, 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)

FDA data resources