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510(k) K871424

ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER by Hgm, Inc. — Product Code LMS

K871424 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER". The FDA issued a decision of Substantially Equivalent on July 8, 1987. The device falls under product code LMS (Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology), a Class II device regulated under 21 CFR 874.4490. Hgm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1987
Date Received
April 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Device Class
Class II
Regulation Number
874.4490
Review Panel
EN
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 LMS

  • K855146 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL (April 11, 1986)

FDA data resources