Identity
- Trade Name
- GEL-ONE FDA PMA
- Generic Name
- Acid, hyaluronic, intraarticular FDA PMA
Identifiers
- PMA Number
- P080020 FDA PMA
- FDA Product Code
- MOZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Gel-One is a hyaluronic acid intra-articular injection indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics such as acetaminophen. It is a sterile, single-use device designed for intra-articular administration.
The device is supplied as a pre-filled syringe for use in clinical settings by healthcare professionals. It is intended for single-use only and must be stored according to manufacturer specifications. Gel-One has received FDA PMA authorization (P080020) and is classified under product code MOZ.
Frequently asked questions
What is Gel-One used for?
Gel-One is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics such as acetaminophen, as stated in the device's approval documentation.
Is Gel-One a reusable device?
No, Gel-One is a single-use device supplied as a pre-filled syringe and is not intended for reuse, as indicated by its specifications and intended use for intra-articular injection.
What regulatory authorization does Gel-One have?
Gel-One has received FDA Premarket Approval (PMA) under application number P080020, as explicitly stated in the AUTHORIZATIONS and pma_number fields of the device data.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P080020 | Class III | Active |
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Manufacturer
- Manufacturer
- Seikagaku Corp.
Sources (1)
- FDA PMA P080020 24 fields · synced Sep 18, 2026