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510(k) K864948

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE by Bio Quantum Technologies, Inc. — Product Code LNK

K864948 is an FDA 510(k) premarket notification submitted by Bio Quantum Technologies, Inc. for the device "ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE". The FDA issued a decision of Substantially Equivalent on March 30, 1987. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Bio Quantum Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
December 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

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)
  • K840406 — MICROSURGICAL CO2 LASER SYS - 4100 (August 20, 1984)
  • K837110 — MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM (March 11, 1983)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)

FDA data resources