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510(k) K864946

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

K864946 is an FDA 510(k) premarket notification submitted by Bio Quantum Technologies, Inc. for the device "ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Bio Quantum Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1988
Date Received
December 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
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)
  • 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)
  • K837110 — MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM (March 11, 1983)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)

FDA data resources