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510(k) K837110

MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM by Bio Quantum Technologies, Inc.

K837110 is an FDA 510(k) premarket notification submitted by Bio Quantum Technologies, Inc. for the device "MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 11, 1983. Bio Quantum Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1983
Date Received
January 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Bio Quantum Technologies, Inc.

  • K934089 — BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S (February 3, 1994)
  • K864946 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE (January 28, 1988)
  • K864887 — ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU (April 10, 1987)
  • K864948 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE (March 30, 1987)
  • K840406 — MICROSURGICAL CO2 LASER SYS - 4100 (August 20, 1984)

FDA data resources