Surgical Light 22 Series

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

510(k) Number

K781581 ↗

FDA Product Code

FQP

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Biological/Chemical Indicator Proof Flash

  Class II

  FDA 510(k) K850144 Active Cleared 17 Jun 1985

• Minor Surgical Light Model 180

  Class II

  FDA 510(k) K841360 Active Cleared 24 Apr 1984

• Hall Arterial Oscillator

  Class II

  FDA 510(k) K801063 Active Cleared 26 Sep 1980

• Vantage E

  Class II

  FDA 510(k) K841156 Active Cleared 13 Apr 1984

• Amsco Orthographic 2 Table

  Class I

  FDA 510(k) K823772 Active Cleared 14 Jan 1983

• Amsco SQ240 Surgical Light

  Class II

  FDA 510(k) K943288 Active Cleared 17 Oct 1994

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• What types of surgical settings is the Surgical Light 22 Series designed for, and how does it enhance visibility during procedures?

  The Surgical Light 22 Series is specifically designed for general and plastic surgery settings, where precise illumination is critical. Its adjustable lighting features are engineered to provide focused illumination, reducing shadows and glare to improve visibility and surgical precision during procedures.

• Is the Surgical Light 22 Series intended for single-use or reusable applications, and how is it typically installed?

  The Surgical Light 22 Series is a reusable device, not intended for single-use. It is typically mounted on surgical carriers, ceiling fixtures, or used as standalone floor-standing units to provide flexible placement in the operating room.

• What regulatory pathway was followed for the FDA clearance of the Surgical Light 22 Series, and what does this mean for its use?

  The Surgical Light 22 Series received FDA clearance through a 510(k) submission (K781581) under the Traditional pathway, determined to be *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II surgical operating-room lamp, regulated under 21 CFR 878.4580, and is approved for use in general and plastic surgery environments.

• How is the sterility of the Surgical Light 22 Series managed, and what does this imply for its use in the operating room?

  The Surgical Light 22 Series is supplied as a *non-sterile* device, meaning it is not pre-sterilized for direct patient contact. Since it is reusable, it must be cleaned and disinfected between uses according to standard surgical instrument protocols to maintain hygiene and prevent contamination in the operating room.

• Are there multiple configurations or models available for the Surgical Light 22 Series, and how might this affect my purchase decision?

  While the data does not specify exact model variations (e.g., wattage, beam angles, or mounting options), the Surgical Light 22 Series is listed with multiple FEI numbers in the FDA database, suggesting potential variations in registration or production batches. For precise configurations—such as adjustable intensity, color temperature, or mounting compatibility—consult the manufacturer’s technical specifications or contact American Sterilizer Co. directly to ensure the model meets your facility’s requirements.