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510(k) K864610

CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE by Inframed, Inc. — Product Code LLF

K864610 is an FDA 510(k) premarket notification submitted by Inframed, Inc. for the device "CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE". The FDA issued a decision of Substantially Equivalent on June 18, 1987. The device falls under product code LLF (Laser, Neurosurgical, Argon), a Class III device. Inframed, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1987
Date Received
November 20, 1986
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 Inframed, Inc.

  • K852761 — CILAS MODEL YM101 (November 14, 1985)
  • K844178 — MODEL TT25RF (October 18, 1985)

Other clearances for product code LLF

  • K870773 — ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (July 10, 1987)
  • K860977 — MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (October 16, 1986)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)

FDA data resources