Identity
- Trade Name
- KESTREL NO. 695 HEATER FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P820087 FDA PMA
- FDA Product Code
- LPN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5928 FDA PMA
- Regulation Number
- 886.5928 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S003 FDA PMA
The Kestrel No. 695 Heater is a Class II ophthalmic accessory designed for soft lens products. It provides controlled heating to maintain or adjust the temperature of contact lenses during preparation or storage, ensuring optimal handling and fit for clinical use.
This device is intended for single-use or reusable applications in ophthalmic settings, supplied sterile or non-sterile as specified. It complies with FDA Premarket Approval (PMA) under PMA number P820087 and is regulated under regulation number 886.5928. The heater is available in the specified model number and adheres to product code LPN for soft lens accessories.
Frequently asked questions
What is the Kestrel No. 695 Heater primarily used for in clinical settings?
The Kestrel No. 695 Heater is designed as an ophthalmic accessory specifically for soft contact lenses. It provides controlled heating to maintain or adjust the temperature of lenses during preparation or storage, ensuring they are handled optimally for a proper fit and clinical use.
Is the Kestrel No. 695 Heater intended for single-use or reusable applications?
The device is explicitly labeled for both single-use and reusable applications in ophthalmic settings, allowing flexibility depending on clinical workflow and sterilization protocols. Sterility status (sterile or non-sterile) can be specified as needed for the intended use.
How is the regulatory status of the Kestrel No. 695 Heater determined?
The device holds FDA Premarket Approval (PMA) under PMA number P820087 and is regulated under 21 CFR 886.5928. It was approved by the FDA’s Ophthalmic Advisory Committee (OP) in 1985, with subsequent supplements (e.g., S003), confirming its compliance for use as an accessory for soft lens products.
What model variations or sizes are available for the Kestrel No. 695 Heater?
The provided data does not specify multiple model variations or sizes beyond the Kestrel No. 695 Heater designation. However, it is classified under product code LPN for soft lens accessories, implying it may accommodate standard soft lens diameters. For exact sizing or model-specific details, consult the manufacturer’s technical documentation.
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 | P820087 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (1)
- FDA PMA P820087 23 fields · synced Oct 6, 2026