Identity
- Trade Name
- ADATOMED SILICONE OIL OP5000 FDA PMA
- Generic Name
- Fluid, intraocular FDA PMA
Identifiers
- PMA Number
- P910071 FDA PMA
- FDA Product Code
- LWL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.4275 FDA PMA
- Regulation Number
- 886.4275 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
ADATO SIL-OL 5000 Silicone Oil is an intraocular fluid classified under the generic name 'Fluid, intraocular'. It is intended for use in ophthalmic surgical procedures as a tamponading agent.
The device is supplied as a sterile, single-use product. It is regulated under FDA PMA authorization P910071 and is intended for use by trained ophthalmic surgeons in a clinical setting.
Frequently asked questions
What is the primary medical use of ADATO SIL-OL 5000 Silicone Oil?
ADATO SIL-OL 5000 Silicone Oil is used as an intraocular fluid in ophthalmic surgery, specifically as a tamponading agent to support retinal reattachment during vitreoretinal procedures.
Is ADATO SIL-OL 5000 Silicone Oil reusable or single-use?
ADATO SIL-OL 5000 Silicone Oil is supplied as a sterile, single-use device, meaning it is intended for one procedure and one patient only, and should not be reprocessed or reused.
What regulatory authorization does ADATO SIL-OL 5000 Silicone Oil have?
ADATO SIL-OL 5000 Silicone Oil has received FDA Premarket Approval (PMA) under application number P910071, which was approved on November 4, 1994.
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 | P910071 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch and Lomb
- FDA Applicant
- Bausch & Lomb
Sources (1)
- FDA PMA P910071 24 fields · synced Sep 18, 2026