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Hydrelle

FDA PMA

Class III (US FDA PMA)

PMA P050033

by Anika Therapeutics, Inc.

Identity

Trade Name
HYDRELLE FDA PMA
Generic Name
Implant, dermal, for aesthetic use FDA PMA

Identifiers

PMA Number
P050033 FDA PMA
FDA Product Code
LMH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APWD FDA PMA

The Hydrelle is a dermal implant classified as an Implant, Dermal, for Aesthetic Use, designed for cosmetic tissue augmentation. It is intended for injection into the mid to deep dermis to correct moderate to severe facial wrinkles and folds, including nasolabial folds. Constructed as a soft, biocompatible filler, it provides volume restoration and contour enhancement through subcutaneous placement.

Hydrelle is supplied as a sterile, single-use device and is regulated under an FDA Premarket Approval (PMA). It is administered via injection in a clinical setting, typically by a trained professional in plastic surgery. The device is available in multiple lot-specific registration numbers and is intended for use in accordance with the approved labeling, ensuring compliance with cosmetic augmentation standards. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is the primary purpose of the Hydrelle dermal implant, and where is it intended to be placed in the body?

The Hydrelle is designed for cosmetic tissue augmentation, specifically to correct moderate to severe facial wrinkles and folds, including nasolabial folds. It is intended for injection into the mid to deep dermis, providing volume restoration and contour enhancement through subcutaneous placement.

Is the Hydrelle implant single-use or reusable, and how is it supplied?

The Hydrelle is supplied as a sterile, single-use device, meaning each unit is intended for one-time use only. It is administered via injection in a clinical setting, typically by a trained professional in plastic surgery.

What regulatory pathway does the Hydrelle follow, and what does this mean for its use?

The Hydrelle is regulated under an FDA Premarket Approval (PMA), which means its safety and effectiveness have been thoroughly evaluated by the FDA. This approval ensures the device meets strict standards for cosmetic tissue augmentation and can only be used as specified in the approved labeling.

Are there multiple versions or sizes of the Hydrelle, and how would I identify them?

Yes, the Hydrelle is available in multiple lot-specific registration numbers (e.g., 1000118068, 3007093114, etc.), which help track individual batches. These lot numbers are not tied to specific sizes but are used for inventory and compliance purposes. The device itself does not have publicly listed size variations in the provided data.

Can the Hydrelle be used in patients who require MRI scans, and what storage conditions are recommended?

The provided data does not specify MRI safety information for the Hydrelle, so its compatibility with MRI procedures is unclear. Regarding storage, no explicit conditions (e.g., temperature, humidity) are detailed in the regulatory records, so adherence to standard sterile medical device storage guidelines is advised until further clarification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Anika Therapeutics, Inc.

Sources (1)

  • FDA PMA P050033 24 fields · synced Sep 18, 2026