Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O
Page 73 of 92
4.11.3
Expected Responses to Treatment
Edema: Mild to moderate edema (swelling) typically develops immediately after treatment
and diminishes, or resolves within the first several days post-treatment. A small degree of
swelling may last longer in some cases.
Erythema: Mild to moderate erythema (redness) typically develops immediately after
treatment and diminishes or resolves, within the first several days post-treatment. A small
degree of redness may last longer in some cases.
Itching / Dryness of the Treated Area: These are common symptoms once the skin has
healed initially. Flakiness and dry crusting will gradually clear. Use of bland moisturizers
and/or moisturizing sunscreens that have previously been shown to not cause irritation
should help this condition.
Pain or Discomfort: Post-treatment, most patients report a feeling similar to sun
overexposure, which usually dissipates within 1 to 3 hours. Post-treatment ice packs may
be applied to alleviate discomfort. Over-the-counter itch and pain relievers may be used if
necessary (e.g. Benadryl, Claritin, Tylenol etc). Solta has no knowledge of the effects of
NSAIDS on the outcome of treatment.
Petechiae/ Pinpoint Bleeding: Although rare, may occur and typically self-resolve without
sequelae
Laser Cuts: Although rare, may occur and typically self-resolve without sequelae
4.12 Treatments Required and Treatment Intervals
Everyone’s skin is different, but clinical studies suggest that for most patients, maximum
results can be achieved in 3-5 sessions with the 1550 nm wavelength or 1-3 sessions with
the 1927 nm wavelength. Treatments are usually spaced 2-6 weeks apart, at physician’s
discretion.
4.13 Complaints and Adverse Effects
Complaints and Adverse Events are reportable under FDA Guidelines. Solta Medical
follows MDR (Medical Device Reporting) rules for complaint and adverse event handling.
Solta Customer Service should be contacted if the Fraxel Laser Systems are involved in a
complaint or adverse event.
