Safety and performance should be at the top of your list when purchasing a laser for your aesthetic practice. However, when there are a multitude of devices on the market, what can help you make sure you invest in one that meets your standards? One major indicator is FDA clearance. Whether you’re a new business owner or expanding your clinic, understanding the importance of FDA-cleared aesthetic lasers can help you make informed purchasing decisions and protect your patients and your reputation.
What Does FDA Clearance Mean?
FDA clearance is a critical indicator that an aesthetic laser has been rigorously evaluated for safety and effectiveness. It means the device has undergone a thorough review and meets the standards set by the Food and Drug Administration, which are vital for protecting patient health and ensuring reliable treatment outcomes.
For practitioners, using an FDA-cleared laser instills greater confidence in the technology, knowing that the device has been evaluated for performance and potential risk factors. It also provides reassurance for patients, who can feel more secure about the procedures being performed, understanding that the treatments adhere to industry regulations.
Verifying FDA clearance is essential when comparing aesthetic laser systems. It ensures you’re choosing a medical-grade device that aligns with industry and legal requirements. In contrast, choosing a system that does not have FDA clearance can put your practice at legal risk and may limit the range of treatments you can offer.
Why FDA Clearance Matters for Your Aesthetic Business
Investing in FDA-cleared aesthetic lasers builds trust with clients and elevates your brand’s credibility. Today’s patients are more informed than ever and want to know that the technology used in their treatments is medical-grade and approved by health authorities.
There are a couple of non-negotiable reasons to think about when looking for an aesthetic laser:
- Patient Safety: FDA clearance ensures that your device performs as intended and, if safe for all skin types, can be used to treat your entire clientele.
- Clinical Results: Having proof of successful results can help promote the treatment capabilities of the device safely.
- Liability: Using non-cleared devices can increase the risk of legal issues or insurance complications.
Aesthetic Laser Equipment to Avoid
Unfortunately, many low-cost devices are not FDA-cleared and make misleading claims about their capabilities. As tempting as it may be to purchase one of the cheaper devices, non-cleared lasers often result in equipment failure, patient complaints, and lost revenue, costing you more in the long run.
If you’re in the market for aesthetic laser equipment, always ask the manufacturer or laser distributor for proof of FDA clearance or research their 510(k). Reputable companies will provide documentation, explanations on the treatment capabilities, and support throughout the lifetime of your laser device.
Dive Deeper – Join Astanza’s Free Webinar
Have some burning questions you’d like answered from our expert team? We’re hosting a LIVE webinar, “The Importance of FDA Clearance for Your Aesthetic Laser”, on June 18th at 6 p.m. CT. Join us as we break down what FDA clearance means, red flags to look out for, and Astanza’s product line.
Hear directly from laser experts and get tips that will help you make safer business decisions. Reserve your spot now!
Contact Astanza
Looking for more details on our aesthetic laser equipment? We’re happy to answer any questions!
Call (800) 364-9010 or email info@astanzalaser.com to get details on our FDA-cleared laser devices.
