Accu-Beam 1101

• FDA 510(k) K864378 decided 5 Mar 1987 Active
• FDA GUDID UDI-DI B17711010 listed 7 Jul 2016 Listed

1. 5 Mar 1987 Cleared FDA 510(k) K864378
2. 7 Jul 2016 Listed FDA GUDID B17711010

Trade name

Accu-Beam

Generic name

Laser adaptor

Model / reference

1101

Primary DI / UDI-DI

B17711010

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).

• MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. by Cooper Lasersonics, Inc.
• MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN by Hgm, Inc.
• FYODOROV RADIAL KERATOTOMY MARKER SET by Med-Tech Develoment Corp.
• ABDOMINAL PRESSURE CONTROL VALVE by L.A.S.E.R., Inc.
• CO2 LASER MICROMANIPULATOR by Transamerican Technologies Intl.
• MODEL 20-C, RL-20A/U, OB-10A/U by Directed Energy, Inc.
• FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA by Laser Media
• CARBON DIOXIDE LASER ML 825 by Merrimack Laboratories
• LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE by LASER PERIPHERALS LLC.
• MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE by Directed Energy, Inc.

• 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 →