Nordlys 9SYS7751-CNDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817495023434), received between Dec 9, 2022 and Jul 21, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A CUSTOMER AT A CLINIC IN FRANCE REPORTED AN ADVERSE EVENT FOLLOWING TREATMENT OF A MALE PATIENT WITH FITZPATRICK SKIN TYPE 4. THE PATIENT RECEIVED NORDLYS ND:YAG TREATMENT OF VASCULAR LESIONS ON THE TOP OF THE NOSE RESULTING IN SCARS. THIS WAS THE PATIENT'S SECOND TREATMENT. THE PATIENT HAD NO RELEVANT PATIENT HISTORY, NO RECENT SUN EXPOSURE; THE SKIN WAS CLEANED WITH MICELLAR WATER AND TREATED WITH ND:YAG 1064, 3 MM SPOT SIZE, A FLUENCE OF 259.9 J/CM2, AND 32 MS PUSLE DURATION WITH ZERO PULSE DELAY. VESSELS WERE TREATED WITH ONE (1) PULSE IF SMALL VESSEL AND TWO (2) PULSES IF LONG VESSEL. THE PATIENT HAD A "CLASSIC VASOCONSTRICTION" REACTION POST-TREATMENT AND WAS PROVIDED CICALFATE. THE DOCTOR IS TREATING THE SCARS WITH NON-ABLATIVE FRACTIONAL LASER (NAFL) AND EXPECTS THE INJURY TO HEAL. PER REVIEW BY CANDELA MEDICAL DIRECTOR, THE SCAR CAN BE IMPROVED WITH RESURFACING AT A LATER DATE AND WILL NOT AFFECT FUNCTION; HOWEVER, THE DEFECT IS DEEP AND THEREFORE, CANDELA IS REPORTING THIS COMPLAINT.

  Patient problems: Scar Tissue

  MAUDE report 22561353 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WITH INITIAL (B)(6) SKIN TYPE III WAS TREATED WITH A NORDLYS VL 555 APPLICATOR FOR THE TREATMENT OF A PORT-WINE STAIN ON HER NECK, DURING A PROVIDER TRAINING AT A CLINIC IN SPAIN ON (B)(6) 2022. THE PATIENT DID NOT HAVE A HISTORY OF PRIOR SUN EXPOSURE. A BURN WAS NOTED IMMEDIATELY POST-TREATMENT. BLASTOESTIMULINA CREAM COVERED WITH LINITUL DRESSING AND GAUZE AND ICE PACKS WERE APPLIED IMMEDIATELY AFTER TREATMENT. DERMATOLOGIC AND AESTHETIC TREATMENT RELATED BURNS THAT TEND TO BE LOW GRADE AND SUPERFICIAL (I.E., FIRST-DEGREE AND SECOND DEGREE) ADDITIONALLY, THE INFORMATION REPORTED DID NOT INDICATE THERE WAS A DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION WITH THIS EVENT; THEREFORE, NOT A REPORTABLE INJURY. ON (B)(6) 2022 THE CANDELA CLINICAL TRAINER RECEIVED NEW INFORMATION/ IMAGES FROM THE CUSTOMER SITE OF THE PATIENT'S BURN. IT WAS NOTED THAT THE TREATMENT PROVIDER, A PLASTIC SURGEON, FOLLOWED UP WITH THE PATIENT AND DEBRIDED THE BURN AREA, AND PRESCRIBED CHLORHEXIDINE SOAP AND GAUZE WITH SILVEDERMA CREAM, AND COVERING THE AREA FROM SUN EXPOSURE. FOLLOW-UP INFORMATION INDICATED THAT THE INJURY IS EXPECTED TO HEAL. NEW INFORMATION INCLUDING P

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 15954883 ↗