Recipient: CuraeLase, Inc
Product:CL 1000 IR Laser System
Date: 12/9/2011
Quality System Regulation Concerns
We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820):
6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by 21 CFR 820.181 (a). For example, there was no documentation of the software specifications and testing of the software user interface and control program. The device has an embedded software program that controls the time elements of the laser and treatments. When the protocol and time treatment duration is selected, the software controls how long the laser is on and the total time, which varies from 5 to 20 minutes.
The embedded software program was developed by the laser (resonator) manufacturer, (b)(4) Although the overall requirements for the software program were communicated between (b)(4), these requirements were not formalized
FDA office: CDRH
