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510(k) K853927

LASE SYSTEM II by James L. Geraci & Associates, Inc.

K853927 is an FDA 510(k) premarket notification submitted by James L. Geraci & Associates, Inc. for the device "LASE SYSTEM II". The FDA issued a decision of Substantially Equivalent on October 16, 1985. James L. Geraci & Associates, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by James L. Geraci & Associates, Inc.

  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K820079 — AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL (February 5, 1982)
  • K820078 — DRAPE, SURGICAL (February 4, 1982)
  • K811698 — CARL ZEISS INN MYRINGOTOMY TUBE LINE (August 31, 1981)

FDA data resources