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ISOLAZ® 2 SYSTEM. - COFEPRIS Registration 584E2019 SSA

Access comprehensive regulatory information for ISOLAZ® 2 SYSTEM. (ISOLAZ® 2 SYSTEM.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 584E2019 SSA and manufactured by BAUSCH & LOMB MÉXICO, S.A. DE C.V.. The device was registered on March 20, 2019.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase II
584E2019 SSA
ISOLAZ® 2 SYSTEM.
COFEPRIS Analysis ID: 584E2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA ISOLAZ® 2 ESTÁ INDICADO PARA EL TRATAMIENTO DE ACNÉ LEVE A MODERADO, INCLUYENDO EL ACNÉ PUSTULOSO, EL ACNÉ COMEDÓNICO Y EL ACNÉ INFLAMATORIO LEVE A MODERADO (ACNÉ VULGAR) EN TODOS LOS TIPOS DE PIEL (I-VI EN LA CLASIFICACIÓN DE FITZPATRICK). EL

English

THE ISOLAZ® 2 SYSTEM IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ACNE, INCLUDING PUSTULAR ACNE, COMEDONIC ACNE AND MILD TO MODERATE INFLAMMATORY ACNE (ACNE VULGARIS) ON ALL SKIN TYPES (I-VI IN THE FITZPATRICK CLASSIFICATION). THE

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE LUZ PULSADA INTENSA PARA EL TRATAMIENTO DEL ACNÉ.
Trade Name (English)
INTENSE PULSED LIGHT SYSTEM FOR THE TREATMENT OF ACNE.
Registration Information
Analysis ID
584E2019 SSA
Registration Date
March 20, 2019
Manufacturer / Fabricante
Name (English)
BAUSCH & LOMB MÉXICO, S.A. DE C.V.