Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O
Page 39 of 92
2.5 Definitions
This section of the manual should familiarize the physician with the terminology used in the
Solta Training Program and describe other features of the Fractional Photothermolysis
process. It is the responsibility of the physician to fully understand the indications for use,
safety considerations and laser function associated with the Fraxel 1550, Fraxel 1927, and
Fraxel DUAL 1550/1927 Laser Systems, and to make medical decisions regarding the
specific application of the Laser Systems to the individual patient.
MTZ
An MTZ is a Microscopic Treatment Zone, the region of coagulated tissue resulting from one
pulse from the handpiece.
Pass
A “pass” is a single, unidirectional hand motion laying down one segment of MTZs.
Magnified it will be similar to the pattern shown below although the spot pitch and stride may
not be identical.
MEND
A MEND is a Micro-Epidermal Necrotic Debris particle. This is a compact accretion of
necrotic epidermal debris which is being pushed up from the Dermal/Epidermal junction and
expelled as a part of the healing process. MENDS produced by the non-ablative Fraxel
Laser Systems typically flake off after 4 – 14 days. During the flaking process they give the
skin a slightly bronzed appearance.
2.6 Parameter
Selection
The physician and all operators should be adequately trained in laser safety and should
make informed and appropriate selection of treatment parameters. The following parameter
set was used as part of the initial safety and efficacy IDE protocol for the first generation
non-ablative Fraxel SR Laser System. Refer to publications and clinical education materials
for additional guidelines.
“The directions for use provided in this section are based on the results of a clinical trial
conducted by Solta Medical, Inc. A total of 27 subjects received a total of 4 non-ablative
