Lombart (Polymacon)Polymer Buttons & Lathe Ll-38l

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

P880102 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (Normal 180 Day Track)

• Ll-55 (Methafilcon a) for Daily Wear

  Class II

  FDA 510(k) K941877 Active Cleared 14 Jun 1994

• Ll Bi-Focal, Daily Wear Contact Lens

  Class II

  FDA 510(k) K971647 Active Cleared 15 Jul 1997

• Soft-55 Daily Wear Contact Lens

  Class II

  FDA 510(k) K961428 Active Cleared 21 May 1996

• Finished Methafilcon A Contact Lenses

  Class III

  FDA PMA P890049 Withdrawn Approved 28 Sep 1989

• Saulfon PW-70 A&B

  Class III

  FDA PMA P840031 Withdrawn Approved 12 Apr 1985

• What is the primary purpose of the LL-38L lathe in ophthalmic manufacturing, and how does it contribute to soft contact lens production?

  The LL-38L lathe is specifically designed for precision machining of polymacon polymer buttons, which are used as blanks in the manufacturing process of daily-wear soft contact lenses. It cuts and shapes these buttons to the required specifications, ensuring consistent quality for lens production in ophthalmic facilities.

• Is the LL-38L lathe intended for single-use or reusable applications, and what maintenance considerations should be noted?

  The LL-38L lathe is not single-use—it is a reusable medical device intended for use in ophthalmic manufacturing facilities. Since it requires proper maintenance and calibration to ensure consistent lens production, users must follow manufacturer guidelines to uphold performance and accuracy over time.

• What regulatory pathway does the LL-38L lathe follow, and how does this affect its use in clinical or manufacturing settings?

  The LL-38L lathe is authorized under FDA Premarket Approval (PMA P880102) and classified as a Class II device (regulation number 886.5925). This means it has undergone rigorous review to ensure safety and effectiveness for its intended use in ophthalmic manufacturing, not direct clinical patient care. Its approval status does not apply to end-user clinical applications but confirms its suitability for precision lens production.

• Does the LL-38L lathe have any special handling requirements, such as sterility or storage conditions?

  The device data does not specify sterility requirements for the LL-38L lathe itself, as it is a manufacturing tool rather than a patient-facing instrument. However, since it operates in an ophthalmic facility, it should be stored in a clean, controlled environment to prevent contamination and ensure optimal performance. Maintenance protocols should include regular cleaning and calibration to comply with manufacturing standards.