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510(k) K870773

ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER by Hgm, Inc. — Product Code LLF

K870773 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER". The FDA issued a decision of Substantially Equivalent on July 10, 1987. The device falls under product code LLF (Laser, Neurosurgical, Argon), a Class III device. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical, Argon
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Hgm, Inc.

  • K950120 — SMART PLUG (August 11, 1995)
  • K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (November 10, 1994)
  • K931784 — HGM ILLUMINATING IMAGING ENDOCULAR PROBE (March 1, 1994)
  • K933333 — HGM SCANMAN PLUS (September 23, 1993)
  • K931499 — Q-11 OPHTHALMIC LASER (August 19, 1993)
  • K925663 — HGM ASPIRATING ENDOOCULAR(TM) PROBE (August 17, 1993)
  • K930543 — E-25 KRYPTON ION LASER (SURGICA K5) (June 22, 1993)
  • K880908 — MODEL PC ARGON LASER (May 3, 1988)
  • K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (October 13, 1987)
  • K872630 — ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (August 25, 1987)

Other clearances for product code LLF

  • K864610 — CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (June 18, 1987)
  • K860977 — MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (October 16, 1986)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)

FDA data resources