All information published in this website is of general nature and only has an informative purpose. Under no circumstances can it replace any treatment or therapy prescribed by a physician or other healthcare professional. Any information on medical procedures and treatments in this website are intended for informative purposes only and do not provide the knowledge required for their application.
All Fotona medical lasers are CE marked and cleared for sale in the EU. For countries where specific national approvals or clearances are required (for example by the FDA in the United States), some of the products and/or applications may not have been cleared yet. Similarly, local patents may limit usage for certain technologies and applications. Please check with Fotona, your local Fotona distributor or your national regulatory body to find out whether a specific product or application is available for sale and use in your country.
Frequently asked questions
How do the Fotona SMOOTH® procedures differ from other, similar laser procedures in gynecology?
All Fotona SMOOTH® treatments are based on a patented mode of Er:YAG laser pulses that are delivered to the vaginal wall mucosa, generating controlled and optimal distribution of heat within the tissue and enabling collagen remodeling and neocollagenesis.
The 2.94 μm wavelength, in conjunction with the patented Fotona SMOOTH® mode delivery, allows for a highly controlled, safe procedure with no impact to any critical structures, including any penetration or disruption of the mucosal surface. That makes the procedures gentle and safe, without compromising effectiveness.
Is local anesthesia necessary to apply prior to treatment?
Local anesthesia is not required, as the treatment is not painful (up to 3 on a 1 to 10 VAS scale). However, some physicians use topical anesthetic cream to completely avoid any discomfort, especially for sensitive patients.
Are the patients required to have a gynecological examination prior to taking the treatment?
Yes, a standard gynecological examination, including a pap-smear, should be performed prior to receiving the treatment.
Are there any contra indications for Fotona SMOOTH® treatment?
Yes, these include some pre-existing conditions and pathologies, which are comprehensively stated in the application manuals. Some contraindications include pregnancy, positive Pap-smear, vaginal infections or injuries and other pathologies.
How soon should the patients expect results after having the procedure?
Although an improvement of symptoms is usually noticed already a few days after the procedure, optimal results start to show from one month to six weeks after the initial treatments, as the effects are due to the formation of new collagen in the treated tissue.
How many treatment sessions are necessary?
Two to three procedure sessions with 4-6 week intervals are standardly performed and achieve optimal results. However, some patients may require additional treatments.
Are the results permanent?
The results have been shown to be stable up to 18 months post-treatment. After this they start to slowly diminish. A maintenance treatment of one session per year is thus advised after the initial series of sessions to achieve lasting optimal results.
What is the down time for the patient?
This is a walk in / walk out procedure, although, patients should abstain from lifting heavy objects and undertaking long periods of sustained exercise for a period of up to 14 days.
How long after the treatment can a patient become sexually active?
In order to achieve the best results, it is recommended that patients abstain from sexual intercourse for a period of between one to two weeks.
Can the IncontiLase® treatment be performed in cases of severe incontinence?
Yes, we can expect some degree of improvement in most cases, decreasing unwanted leakage and the use of pads, while complete dryness is reached in a much smaller percentage of cases compared to the dryness rates in patients with mild and moderate incontinence.
Can the ProlapLase® treatment be performed in cases of severe pelvic organ prolapse?
Yes, we can expect some degree of improvement in most cases, which may postpone the need for a surgical procedure. In many severe cases, surgery is the only option.
Is it possible to over-tighten the vaginal canal and introitus as a consequence of IntimaLase® treatment?
This cannot be the case as the treatment results in only a slight shrinkage of existing collagen and stimulates the production of natural collagen, enabling regeneration to the pre-condition state.
Is special preparation of the vaginal canal necessary before performing the RenovaLase® procedure in menopausal women?
Some doctors prescribe the patient a local hormonal gel a few weeks prior to the treatment in severe cases of vaginal atrophy, in order to make the treatment more comfortable. However, many doctors and published studies have reported that there is no special preparation necessary.
Can another Fotona laser system perform this treatment?
How long is the learning curve in terms of becoming familiar with the Fotona SMOOTH® procedures?
The procedure is simple to learn and doctors can expect to be able to perform the procedure following a 2-day training course.
Who can perform the treatments?
GenerGenerally, treatments are performed by OB/GYN specialists, although in some countries other specialists can also perform the treatment. We recommend that in such cases, the treatments should be done in close collaboration with a patient gynecologist, in order to obtain the required pre-treatment information.
Do doctors require any specific qualifications apart from the training to perform the treatment?
No, although the question of who can perform the treatment depends on the regulations of the country.
What is the difference between the FotonaSmooth® SP & FotonaSmooth® XS systems?
Which accessories and handpieces are required to perform the treatment?
All Fotona SMOOTH® treatments require a set of accessories named the ”G-set” to perform the treatment. The G-Set includes:
- Laser speculums
- Circular adapter
- Angular adapter
- R11: Full-beam Er:YAG titanium handpiece
- PS03X: Fractionated Er:YAG titanium handpiece
What consumables are necessary and how much will they cost?
In most countries, single-use glass speculums are used. These must be bought from Fotona, as they are designed to fit other required components and to optimally transmit the infrared laser light to the tissue.
How many treatments can be performed by one system?
An unlimited number of treatments can be performed, provided the laser system is in good working order and serviced regularly as advised.
Are the Fotona SMOOTH® procedures safe? What are the side-effects connected to the treatments?
There have been no serious side effects connected to the procedure reported. Side effects are rare and mild, owning to the non-ablative nature of the procedure, leaving the surface of the tissue intact. Most women will experience mild swelling and discomfort for a couple of days. Many clinical studies have proven the safety of the Fotona SMOOTH® procedures. You can read more about the published clinical trials here.
Where can I learn more about the procedures and try them hands’ on?
How many doctors are using Fotona SMOOTH®?
Thousands of users have been working with Fotona SMOOTH® since 2012.
What is the cost of a FotonaSmooth (SP or XS) laser?
To find out the pricing and payment options, please contact your local Fotona distributor.
Will the FotonaSmooth laser be profitable for my clinic?
FotonaSmooth (SP or XS) systems offer more than just the non-invasive Fotona SMOOTH® gynecological treatments. The range of pulse durations and energies make it a versatile laser that can perform many other applications, ranging from scar revision, benign lesion removal, skin tightening, striae treatment, skin resurfacing, etc. The system can be purchased with an additional wavelength, Nd:YAG, which enables a wide spectrum of additional applications. The versatility of possible treatments gives doctors the opportunity for full everyday use of the laser and makes the equipment a highly profitable investment. For more information about the FotonaSmooth system’s configurations, click here.
How often do I need to maintain the FotonaSmooth system and how much will this cost?
It is recommended that all Fotona laser systems are serviced at least once a year (note that this is also a legal requirement in many countries). The cost of servicing varies from country to country. Please check with your local distributor for pricing.