{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5006220", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080410", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20060705", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT FAMILY MEMBER OR FRIEND", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080421", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080410", "brand_name": "OMNILUX BLUE", "generic_name": "LIGHT TREATMENT", "manufacturer_d_name": "PHOTO THERAPEUTICS, INC", "manufacturer_d_address_1": "2720 LOKER AVE WEST", "manufacturer_d_address_2": "STE C", "manufacturer_d_city": "CARLSBAD", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92010", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92010", 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"manufacturer_d_postal_code": "92010", "device_operator": "0", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GEX", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Powered Laser Surgical Instrument", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4810", "device_class": "2" } } ], "product_problems": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20080410", "sequence_number_treatment": [ "OMNILUX BLUE", " OMNILUX BLUE", " OMNILUX BLUE", " OMNILUX BLUE", " OMNILUX RED", " OMNILUX RED", " OMNILUX RED", " OMNILUX RED", " OMNILUX BLUE", " OMNILUX RED" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "15 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Scarring", "Identified diagnosis", "Deterioration" ] } ], "distributor_city": "", "date_report": "20080410", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1028481", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "845026", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "I AM EXPRESSING CONCERNS ON THE OMNILUX LIGHT THERAPY TREATMENT MANUFACTURED BY PHOTO THERAPEUTICS. IN 2006, MY DAUGHTER BEGAN A SERIES OF THE OMNILUX BLUE AND OMNILUX REVIVE TREATMENTS AT THE FACILITY. THE CLINIC IS OWNED AND OPERATED BY DR. SHE WENT THROUGH A SERIES OF 8 TREATMENTS OVER A 4 WEEK PERIOD. BEFORE THE TREATMENT, HER ACNE WAS MILD TO MODERATE. IMMEDIATELY AFTER THE TREATMENT BEGAN, HER ACNE BECAME SEVERE. THE AESTHETICIAN SAID IT WOULD GET WORSE BEFORE IT GETS BETTER AND TO CONTINUE WITH THE TREATMENT. OVER THE COURSE HER ACNE SHOWED NO IMPROVEMENT. INSTEAD, SHE NOT ONLY GOT WORSE BUT DEVELOPED PERMANENT SCARS AND CRATERS AS A RESULT. MY CONCERN IS THAT THERE IS NOT ENOUGH CLINICAL DATA AVAILABLE FOR THE OMINLUX LIGHT THERAPY. THE WEBSITE SHOWS RESULTS FOR ONLY TWO CLINICAL STUDIES. ONE STUDY USING THE OMNILUX BLUE INCLUDED 30 SUBJECTS WITH AN OPTIMUM REDUCTION IN INFLAMMATORY LESIONS OF 73% 4 TO 8 WEEKS POST TREATMENT. THE OTHER STUDY USING A COMBINATION OF OMINLUX BLUE AND OMNILUX REVIVE IN 16 SUBJECTS SHOWED A MEAN CLEARANCE RATE OF OVER 82% 12 WEEKS AFTER THE FINAL TREATMENT. TWO STUDIES WITH ONLY 46 SUBJECTS DO NOT SEEM LIKE SUFFICIENT DATA. I HAVE READ MANY REVIEWS FROM PEOPLE WHO HAVE TRIED THIS TREATMENT WITHOUT ANY RESULTS. ALTHOUGH THE CO STATES THAT THERE ARE NO SIDE AFFECTS, MY DAUGHTER'S TREATMENT NOT ONLY MADE HER ACNE CONDITION WORSE, BUT CREATED PERMANENT SCARS. I WOULD LIKE TO KNOW IF THERE IS ANY DATA THAT SHOWS SUBJECT WITH NO RESULTS OR WORSENED EFFECTS. IF THERE IS DATA, THIS SHOULD BE AVAILABLE TO CONSUMERS WHO ARE CONSIDERING THE OMNILUX TREATMENTS. I AM FILING A COMPLAINT WITH THE MEDICAL BOARD AGAINST DR AND HIS CLINIC FOR NOT TAKING APPROPRIATE ACTION WHEN MY DAUGHTER'S CONDITION WORSENED. A COPY OF THAT LETTER IS AVAILABLE IF DEEMED NECESSARY. DATES OF USE: 1 1/2 MONTHS IN 2008. DIAGNOSIS OR REASON FOR USE: ACNE TREATMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }