saypha® MagIQ™
by Croma-Pharma GmbH United States PMA
PMA P240008
Product code LMH
Overview
saypha® MagIQ is an implant for dermal aesthetic use, designed for injection into the mid to deep dermis to correct moderate to severe facial wrinkles and folds such as nasolabial folds in adults over 21 years of age. It is classified as a Class III medical device and is intended for aesthetic correction of facial wrinkles and folds.
The device is supplied as a sterile implant for single-use and is not indicated for MRI safety. It is manufactured by Croma-Pharma GmbH in Leobendorf, Austria, and has received FDA PMA approval with the authorization number P240008. The device is approved for injection into the mid to deep dermis for aesthetic purposes in adults over 21 years of age.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240008 | Date8 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Implant, dermal, for aesthetic use
- PMA Number
- FDA Product Code
- LMH
- Device Class
- Class III
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
Other devices from Croma-Pharma GmbH
Questions
What is the primary use of the saypha® MagIQ™ implant, and who is it intended for?
The saypha® MagIQ™ is designed for dermal aesthetic use, specifically for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds. It is intended for injection into the mid to deep dermis of adults aged 21 and older.
Is the saypha® MagIQ™ implant single-use or reusable, and how is it supplied?
The saypha® MagIQ™ implant is supplied as a sterile product intended for **single-use only**. This ensures safety and compliance with medical device standards, preventing cross-contamination or reuse-related risks.
Are there multiple sizes or models available for the saypha® MagIQ™ implant, and how are they differentiated?
The data provided lists multiple **FEI numbers** (e.g., 3007093114, 3031983053) and **registration numbers**, which typically correspond to distinct lot or batch identifiers rather than discrete product sizes or models. These identifiers are used for regulatory tracking, not clinical differentiation. The device itself is described as a single implant type without explicit size variations in the provided details.
What storage requirements or handling precautions should be followed for the saypha® MagIQ™ implant?
While specific storage instructions aren’t detailed in the provided data, the implant is **sterile** and intended for single-use. Standard sterile medical device storage practices—such as protecting from contamination, extreme temperatures, and light—should be followed. Always refer to the manufacturer’s (Croma-Pharma GmbH) official labeling or instructions for precise guidance.
What regulatory pathway was followed for FDA approval of the saypha® MagIQ™ implant, and what does this mean for clinicians?
The saypha® MagIQ™ implant received **FDA PMA approval (P240008)**, which is the highest regulatory clearance for Class III medical devices in the U.S. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use—correcting facial wrinkles and folds via mid-to-deep dermal injection in adults over 21. Clinicians can rely on this approval as evidence of the device’s compliance with FDA standards.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P240008