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Light, Surgical, Accessories
FDA product code FTA · Class 2 · General, Plastic Surgery
1,258
Registered devices
391
Adverse events
6
Recalls
26
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.NA — MAQUET SASDeRoyal — DEROYAL INDUSTRIES, INC.LITEX — Litex Manufacturing, Inc.Olympus — Gyrus ACMI, LLCLITEX — Litex Manufacturing, Inc.Aspen® Flexible Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Aspen® Flexible Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.Aspen® Flexible Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.Aspen® Rigid Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.LITEX — Litex Manufacturing, Inc.Physician's Choice — Supply Line International Medical, LLCAspen® Rigid Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.Aspen® Flexible Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.Aspen® Rigid Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.Sterilizable Handle for DoVera DE12 Examination Light Series — SKYTRON LLCAlleset — GRI Medical & Electronic Technology Co., Ltd.Aspen® Flexible Light Handle Adapter — ASPEN SURGICAL PRODUCTS, INC.DeRoyal — DEROYAL INDUSTRIES, INC.LITEX — Litex Manufacturing, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.NA — MAQUET SASLITEX — Litex Manufacturing, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-23 | Steris Corporation | A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images |
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field |
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field |
| 2017-10-13 | Ecolab, Inc. | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
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