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FDA 510(k)

Picosecond Nd:YAG Laser Systems (BL-C10)

K-Number: K240386 · 2024-05-16

ApplicantShanghai Bele Medical Technology Co.,Ltd
Decision Date2024-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picosecond Nd:YAG Laser Systems (BL-C10) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240386. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Picosecond Nd:YAG Laser Systems (BL-C10)?

Picosecond Nd:YAG Laser Systems (BL-C10) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K240386.

When did Picosecond Nd:YAG Laser Systems (BL-C10) receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser Systems (BL-C10) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240386.

Who is the listed applicant for Picosecond Nd:YAG Laser Systems (BL-C10)?

The FDA 510(k) record lists Shanghai Bele Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Picosecond Nd:YAG Laser Systems (BL-C10)?

The FDA product code for Picosecond Nd:YAG Laser Systems (BL-C10) is GEX. This falls under the Gastroenterology category.

Other records listing Shanghai Bele Medical Technology Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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