Heatcase Sterilizer, Soft-Lens, Thermal, AC-Powered

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Heatcase(Tm)

Generic Name

Sterilizer, soft-lens, thermal, ac-powered

PMA Number

P830001 ↗

FDA Product Code

HRD

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

  Class II

  FDA 510(k) K991000 Active Cleared 28 Jun 1999

• Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)C

  Class II

  FDA 510(k) K000439 Active Cleared 20 Mar 2000

• Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K994335 Active Cleared 20 Mar 2000

• Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

  Class II

  FDA 510(k) K993935 Active Cleared 21 Dec 1999

• Precision UV (Vasurfilcon a)

  Class II

  FDA 510(k) K982988 Active Cleared 6 Jan 1999

• Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint

  Class II

  FDA 510(k) K954603 Active Cleared 4 Jan 1996

See all devices from Wesley Jessen Corp. →

• What types of environments or settings is the Heatcase™ designed for, and how does it differ from other contact lens sterilizers?

  The Heatcase™ is specifically designed for ophthalmic settings, such as eye clinics, optometrist offices, or contact lens care centers where soft contact lenses are routinely reused. Unlike some single-use or chemical sterilization systems, it uses thermal processing (heat) to eliminate microbial contamination, making it ideal for environments where thermal sterilization is preferred or feasible. Its AC-powered design ensures compatibility with standard electrical outlets, while its reusable unit structure allows for consistent use in clinical or professional settings.

• Is the Heatcase™ meant for single-use or can it be reused across multiple patients, and how does that affect its maintenance?

  The Heatcase™ is not single-use—it is designed as a reusable unit for repeated use in sterilizing soft contact lenses. However, its effectiveness depends on proper thermal processing and maintenance as outlined in its operational instructions. Since it relies on heat to achieve sterility, the device itself must be cleaned and maintained according to manufacturer guidelines to ensure consistent performance and prevent cross-contamination between uses.

• What power source does the Heatcase™ require, and does it come with any accessories or additional supplies?

  The Heatcase™ operates on standard AC power, meaning it connects to a typical electrical outlet. The device itself is supplied as a reusable unit, but the manufacturer’s instructions likely specify any required accessories (e.g., cleaning tools, replacement parts) or consumables (e.g., lens cases) for proper use. Since it’s thermal-based, no chemical sterilants or single-use components are part of its operation.

• How do I store the Heatcase™ when not in use, and are there any special considerations for its longevity?

  The Heatcase™ should be stored in a clean, dry environment when not in use, following the manufacturer’s guidelines to prevent dust, moisture, or damage. As a reusable thermal sterilizer, its longevity depends on adherence to maintenance protocols (e.g., cleaning, calibration if applicable) and proper handling to avoid wear. Since it’s FDA-authorized under PMA (P830001), it’s classified as Class 2, which typically implies routine inspections or servicing may be recommended to ensure continued performance and safety.