FDA Adverse Event Injury Summary report: N

DENZA

MDR report key: 23367294 · Received October 23, 2025

Report

Report Number
MW5177870
Event Type
Injury
Date Received
October 23, 2025
Date of Event
October 23, 2023
Report Date
October 20, 2025
Manufacturer
REVEAL LASERS LLC.
Product Code
GEI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
117
Health Professional
Yes

Narratives

Description of Event or Problem · 0

REVEAL LASERS LLC MARKETED AND TRAINED ON VAGINAL REJUVENATION WITH AGEJET PLASMA. I WAS NOT INFORMED THIS WAS ILLEGAL AND NON-FDA CLEARED. THIS LED TO PERMANENT VAGINAL DAMAGE TO A CLIENT THAT IS STILL UNDER INVESTIGATION. THE REVEAL LASERS COMPANY ALSO HAD A GEL THEY PROVIDE AND TRAIN ON MADE IN SOUTH KOREA WITH SOUTH KOREAN INGREDIENTS AND THIS CAUSED AN ANAPHYLACTIC REACTION. THE COMPANY DID NOT PROVIDE ANY NEW PROTOCOLS OR SOLUTIONS, AND A MEDICAL DIRECTOR NEVER FOLLOWED UP WITH ME. THE REVEAL LASERS EMPLOYEE, (B)(6) ONLY HAS A FACIAL SPECIALIST LICENSE:(B)(4) AND WAS INTRODUCED BY THE COMPANY AS A NURSE PRACTITIONER AND SHE INTRODUCED HERSELF TO ME AND MY PARTNER, AND PATIENT, AS A NURSE PRACTITIONER. THE COMPANY ALLOWED THIS AND THIS IS DANGEROUS TO MARKET, PRACTICE, AND THERE HAVE BEEN CHRONIC ONGOING SYMPTOMS BECAUSE OF THEIR INABILITY TO ADDRESS MEDICAL CONCERNS. I HIGHLY DOUBT THEY EVEN HAVE A MEDICAL DIRECTOR AND IF SO, THEY ARE NEGLIGENT TO FOLLOW UP. REVEAL IS NEGLIGENT AND FRAUDULENT FOR PROVIDING A TRAINER WHO WAS INFORMED AND INTRODUCED TO MYSELF AND PARTNER AS A MEDICAL PROFESSIONAL WITH A MEDICAL LICENSE. THIS COMPANY ALSO IS PARTNERED WITH NEOCONCEPTS LLC. I HAVE A LITIGATOR WE HAVE FILED A CIVIL SUIT BUT AS A MADATED REPORTER AND THIS INFORMATION JUST BEING UNCOVERED THIS NEEDS TO BE REPORTED AND HAS BEEN DONE SO TO THE HEALTH DEPT, (B)(6), AND A POLICE REPORT WILL BE FILED TOMORROW WHEN I HAVE TIME IN MY SCHEDULE. THIS COMPANY AND EMPLOYEES OF REVEAL AND NOW THEIR NEW (HIDDEN BEHIND A REVEAL NAME) COMPANY NEOCONCEPTS IS SELLING THE SAME DEVICE. PT CODE: 1979. DEVICE CODE: 3190. REF REPORT: MW5177869.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
232636 DENZA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI REVEAL LASERS LLC.

Patients

Seq Age Sex Outcome Treatment
1 35 YR Female Other