LILIS™ Newsletter

June 24, 2008

Welcome to Boston MedTech Advisors

Laser and Intense Light treatments are subject to numerous state regulations which change constantly, frustrating and confusing manufacturers of such devices and providers of such services. Many states have increased the level of scrutiny of health and safety issues related to the use of lasers and intense pulsed light devices for cosmetic treatments. New statutes and regulations have been proposed and task forces to study these issues have been formed. LILIS™ (Laser and Intense Light Information Service) maintains an updated database of relevant regulations and professional board recommendations in all 50 states. We constantly track over 400 state and federal organizations (e.g State Legislatures, Medical and Nursing Boards, etc.) and provide focused, comprehensive, cost-effective reports.

This bulletin brings you an example of the constantly evolving regulations with the focus this time on an FDA warning letter to Sandstone Medical Technologies.

Test Your Regulatory IQ

Registered nurses in ____________ are permitted to perform cosmetic and dermatological procedures with off-site supervision.
a) Kentucky
b) Mississippi
c) Montana
d) Indiana

Scroll to the end of this newsletter for the answer.

Spotlight On:

Sandstone Medical Technologies
On May 30, 2008 the FDA issued a warning letter to Sandstone Medical Technologies, a provider of pre-owned aesthetic lasers. The warning letter details various infractions including failure to maintain complaint files and evaluate whether complaints should be reported to FDA, failure to maintain records of product testing and relabeling of imported labels prior to distribution and inadequate servicing instructions and procedures.

Equipment complaints include instances when a laser:

* Burned a patient
* Would not turn on
* Did not fire or fired by itself
* Had low power
* Was"burning hot"
* Fired after release of the foot switch
* Had a foot switch that was too sensitive

Sandstone is an initial importer, manufacturer and relabeler of Class II medical laser systems.
Click here to view the entire warning letter.

Medical Spa Reports

Complete report of state regulations regarding the use of laser and intense light devices in medical spas.

For more information contact LILIS@bmtadvisors.com

About LILIS™ (Laser and Intense Light Information Service)

LILIS™ helps laser and intense light manufacturers, distributors, clinicians and aesthetic service providers navigate the complex maze of state and federal regulations. We offer:

* Comprehensive information about state and federal regulations
* On-demand phone support
* Personalized service to research your specific regulatory questions
* Accurate, timely and current information
* A variety of service options to meet your needs

About Boston MedTech Advisors

Boston MedTech Advisors assists medical technology companies and healthcare organizations in advancing their business by providing:

* Market analysis and business strategy
* Business development
* Regulatory affairs and clinical trials management
* Reimbursement and contracting strategies
* Financing support

Boston MedTech Advisors provides practical business services to:

* Established and growing medical technology companies
* Healthcare providers
* Young organizations and entrepreneurs
* Private and institutional investors

To learn more about our organization and services, please visit our web site at www.bmtadvisors. com or call us at 781.407.0900

Test Your Regulatory IQ- Answer

d) Kentucky

This document has been prepared by members of Boston MedTech Advisors Inc. The information presented in this document is based on publicly available data and information made available to Boston MedTech Advisors by third parties. This report is intended to provide general information pertinent to the regulation of light therapy. Only a State Attorney General is empowered to render formal opinions concerning State law. Although the report was prepared with reasonable care, Boston MedTech Advisors Inc. does not make any representation or offer any warranty, expressed or implied, as to the information contained herein. This document contains confidential information, and may not be copied or otherwise reproduced without the expressed written consent of Boston MedTech Advisors.