Focus Medical, LLC

Contact information

• Address: 23 Francis J Clarke Circle, Bethel, CT 06801
• Telephone: 203 730-8885
• Fax: 203 730-8851
• website: www.focusmedical.com

Notes:

On April 10, 2007, John Lee sent the following information:

FDA definition of permanent hair reduction and hair removal:

The term "hair removal" or "removal of unwanted hair" is the general claim given to lasers and light systems that have either provided clinical data or are technologically equivalent to devices that have provided clinical data demonstrating hair removal (usually a minimum loss of 30% compared to baseline counts) 3 months after the end of treatment.

The hair reduction claim specifically stated is " to effect stable, long-term or permanent hair reduction where permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime". In this case clinical data was used to establish that the number of hairs counted at 6, 9, and 12 months following the ending of the treatment regime were essentially the same thus demonstrating a "permanent reduction" over an extended period of time. In this case most device required from 3-5 treatments before such a reduction occurs.

Originally we required the full statement as given above for the permanent reduction claim but over time we have become somewhat less rigid since the number of devices having this claim has grown significantly.

The above is directly from the FDA with no editing.

Focus Medical manufactures the following:

NaturaLase LP a Permanent Hair Reduction system. The technology is a Long Pulse Nd:YAG laser system. The NaturaLase 1064 received FDA clearance on 24 April 2000 under another name: the LT-100 Laser Treatment System by LORAD. (FDA docket K992597)

NaturaLight a flash lamp system that is a Permanent Hair Reduction system. The technology is a Q-Switched Nd:YAG laser system.

NaturaLase QS a hair removal laser system that has advantages in gentle treatment and dark skin applications. It is not a permanent hair reduction system.

On 25 January 2001, President John B. Lee of Focus Medical wrote with updated company information:

"Lorad is no longer in the laser business. The 510k was submitted by Lorad and does not get changed when ownership changes. That is why it shows up as Lorad LT100 on the 510k."

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