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510(k) K843518

MINUTEMAN C02 MICROSURG LASER PODIATRY by American Surgical Laser, Inc. — Product Code GEY

K843518 is an FDA 510(k) premarket notification submitted by American Surgical Laser, Inc. for the device "MINUTEMAN C02 MICROSURG LASER PODIATRY". The FDA issued a decision of Substantially Equivalent on December 7, 1984. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. American Surgical Laser, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1984
Date Received
September 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by American Surgical Laser, Inc.

  • K843515 — MINUTEMAN CO2 MICROSURGICAL LASER GYN (February 4, 1985)
  • K843517 — MINUTEMAN CO2 MICROSURG LASER DERMATOL- (December 7, 1984)
  • K843519 — MINUTEMAN CO2 MICROSURG LASER GEN SURG (December 7, 1984)
  • K843514 — MINUTEMAN CO2 MICROSURGICAL LASER OTO (December 4, 1984)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)

FDA data resources