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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1920-2025 - Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Pro SuperPulsed Laser System
Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only);
Product Description: SOLTIVE Laser Systems u...
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2
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06/06/2025
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FEI # 2429304 Olympus Corporation of the Americas
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Z-1923-2025 - Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive Reusable Laser Fibers
Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan...
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2
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06/06/2025
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FEI # 2429304 Olympus Corporation of the Americas
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Z-1922-2025 - Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive SuperPulsed Laser Fibers - Single Use
Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TF...
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2
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06/06/2025
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FEI # 2429304 Olympus Corporation of the Americas
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Z-1921-2025 - Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Premium SuperPulsed Laser System
Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only);
Software Version: N/A
Product Descripti...
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2
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06/06/2025
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FEI # 2429304 Olympus Corporation of the Americas
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