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510(k) K871511

SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS by Medical Energy, Inc. — Product Code LLO

K871511 is an FDA 510(k) premarket notification submitted by Medical Energy, Inc. for the device "SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Medical Energy, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
April 20, 1987
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 Medical Energy, Inc.

  • K041419 — LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM (August 26, 2004)
  • K871512 — SL-100 ND:YAG LASER FOR GYNECOLOGY USE (July 8, 1988)
  • K871516 — SL-100 ND:YAG LASER FOR UROLOGIC SURGERY (July 9, 1987)
  • K871513 — SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI (July 9, 1987)
  • K871515 — SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING (July 9, 1987)
  • K871514 — SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID (July 9, 1987)

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)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources