DOLORCLAST聚焦冲击波
K号: K243279 · 2025-08-13
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决定日期2025-08-13
产品代码PZL
咨询委员会SU
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决定实质等同
器械摘要
DOLORCLAST Focused Shock Waves is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243279. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DOLORCLAST Focused Shock Waves?
DOLORCLAST Focused Shock Waves is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K243279.
When did DOLORCLAST Focused Shock Waves receive FDA 510(k) clearance?
DOLORCLAST Focused Shock Waves received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243279.
Who is the listed applicant for DOLORCLAST Focused Shock Waves?
The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DOLORCLAST Focused Shock Waves?
The FDA product code for DOLORCLAST Focused Shock Waves is PZL.
相关临床试验
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列明E.M.S Electro Medical Systems S.A为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：PZL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K250779CS-Pro MEDCurative Sound TherapeuticsK233937OW100SSoftwave/Trt, LLCK231710OW100SSoftwave/Trt, LLCK202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AGK200926OrthoGold 100Tissue Regeneration Technologies, LLCK191961OrthoGoldTissue Regeneration Technologies
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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