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510(k) K871516

SL-100 ND:YAG LASER FOR UROLOGIC SURGERY by Medical Energy, Inc. — Product Code LNK

K871516 is an FDA 510(k) premarket notification submitted by Medical Energy, Inc. for the device "SL-100 ND:YAG LASER FOR UROLOGIC SURGERY". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Medical Energy, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
April 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
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)
  • K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (July 21, 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 LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources