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510(k) K844460

ND. YAG LASER RECTAL PATHOLOGY by Endo Lase, Inc. — Product Code LNK

K844460 is an FDA 510(k) premarket notification submitted by Endo Lase, Inc. for the device "ND. YAG LASER RECTAL PATHOLOGY". The FDA issued a decision of Substantially Equivalent on January 16, 1985. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Endo Lase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1985
Date Received
November 15, 1984
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 Endo Lase, Inc.

  • K853900 — ENDO-LASE CD40 FOR NEUROSURGERY (June 18, 1986)
  • K853878 — ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY (May 2, 1986)
  • K853903 — ENDO-LASE CD40 CO2 FOR GYNECOLOGY (February 21, 1986)
  • K853876 — ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY (February 21, 1986)
  • K855093 — MEDILAS 2 ND:YAG LASER SURGERY SYSTEM (February 21, 1986)
  • K853877 — ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY (February 19, 1986)
  • K853901 — ENDO-LASE CD 40 FOR DERMATOLOGY (February 19, 1986)
  • K853580 — MEDILAS 2 (February 13, 1986)
  • K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (February 5, 1986)
  • K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY (January 9, 1986)

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