Accu-Beam 1103

• FDA 510(k) K864378 decided 5 Mar 1987 Active
• FDA GUDID UDI-DI B17711030 listed 8 Jul 2016 Listed

1. 5 Mar 1987 Cleared FDA 510(k) K864378
2. 8 Jul 2016 Listed FDA GUDID B17711030

Trade name

Accu-Beam

Generic name

Laser adaptor

Model / reference

1103

Primary DI / UDI-DI

B17711030

510(k) Number

K864378 ↗

FDA product code

HHR

GMDN term

Laser adaptor

Device class

Class II

Regulation number

884.4550

GUDID distribution status

In Commercial Distribution

Category: Laser adaptor

Other devices filed under FDA product code HHR (Laser, Surgical, Gynecologic).

• SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL by Surgical Laser Technologies, Inc.
• ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY by Endo Lase, Inc.
• FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA by Laser Media
• MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE by Sharplan Lasers, Inc.
• MODEL J25-25 WATT CO2 LASER by Britt Corp., Inc.
• CO2 LASER LAPAROSCOPE SYSTEM by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Omniplus Photosurgical Laser System for OB-GYN by Laserscope
• YN CO2 LASER SYSTEM 30W by Cryomedics, Inc.
• SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE by Directed Energy, Inc.
• DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET by Tti Medical

• Accu-Beam 31226-455L

  Class II

  FDA 510(k) K963193 Active Cleared 13 Nov 1996 GUDID on market

• Accu-Beam 0010-0853T-SS

  Class II

  FDA 510(k) K952006 Active Cleared 31 May 1995 GUDID on market

• Accu-Beam 0010-0852T-SS

  Class II

  FDA 510(k) K952006 Active Cleared 31 May 1995 GUDID on market

• Accu-Beam 70050018

  Class II

  FDA 510(k) K864378 Active Cleared 5 Mar 1987 GUDID on market

See all devices from Transamerican Technologies International →