Description of Event or Problem · 1
I WENT TO A MEDICAL SPA TO RECEIVE A FACIAL SERVICE. THE ESTHETICIAN USED A MEDICAL MACHINE, IONIXLIGHT OR OXYLIGHT BY (B)(6) MEDICAL, THAT CAUSED SEVERE HEATING TO MY SKIN TOPICALLY WHEN I HAD A FACIAL AT THE (B)(6) CENTRE IN (B)(6). THIS CAUSED EXTREME SENSITIVITY TO MY ENTIRE FACE AND HAS CAUSED TWITCHING NEAR MY EYES. ALSO THE LED AND MICROCURRENT WAS TOO STRONG CAUSING MUSCLE TWITCHING AND MY EYE AREA TO BE OVERLY SENSITIVE. I HAD SOME BLURRY VISION FOR DAYS AFTER SO HOPEFULLY THE EFFECTS ARE NOT LONG LASTING. I (B)(6) ONLINE TO SEE IF ANYONE HAS HAD THE SAME EXPERIENCE WITH THIS KIND OF FACIAL AND ALSO SEARCHED FOR THIS DEVICE ON THE FDA WEBSITE AND IT IS NOT FDA APPROVED FOR ULTRASOUND, RADIOFREQUENCY, LYMPHATIC DRAINAGE, ETC. DEVICE IS NOT TESTED APPROPRIATELY ON CLIENTS' SKIN. NOT FDA APPROVED DESPITE BEING SOLD AND USED IN MANY MEDICAL SPAS AND FACILITIES FOR MANY YEARS AS I HAVE SEEN ON THEIR WEBSITE (B)(6) AS WELL ON THEIR SOCIAL MEDIA SITES (OXYLIGHT FACIAL AND (B)(6) MEDICAL). THIS MACHINE IS BEING SOLD TO DERMATOLOGISTS AND ESTHETICIANS ACROSS THE COUNTRY AND BEING USED ON CELEBRITIES AND REGULAR INDIVIDUALS LIKE MYSELF. THE ESTHETICIAN EXPLAINED THE DEVICE HAS MICRODERMABRASION, MICROCURRENT, ULTRASOUND, LED LIGHT, LYMPHATIC DRAINAGE, AND RADIOFREQUENCY. AS IT HAS THESE FUNCTIONS AND IT WAS USED ON ME FOR MY SERVICE THEN WHY WASN'T IT TESTED BY THE FDA TO ENSURE IT IS SAFE TO BE USED. SHOULD NOT BE ALLOWED TO BE USED ON CLIENTS AS THE SETTINGS FOR RADIOFREQUENCY AND MICROCURRENT, AND ULTRASOUND ARE NOT APPROPRIATE FOR THE SKIN AND COULD CAUSE DAMAGE LIKE ON MYSELF. AS IT'S NOT FDA APPROVED THERE IS NO WAY TO SHOW IT IS SAFE TO BE USED ON THE SKIN. THIS NEEDS TO BE RECALLED AS THE EFFECTS TO CLIENTS HAVE NOT BEEN MEASURED APPROPRIATELY. TESTING NEEDS TO BE DONE TO SEE IT IS SAFE FOR USE ON THE PUBLIC. THIS SHOULD NOT BE ALLOWED TO HAPPEN TO SOMEONE ELSE. FDA SAFETY REPORT ID # (B)(4).