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FDA 510(k)

LumiGlam Laser System (SHE-LSP601-3)

K-Number: K260690 · 2026-06-04

ApplicantBeijing Sano Laser S&T Development Co.,Ltd
Decision Date2026-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LumiGlam Laser System (SHE-LSP601-3) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260690. 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 LumiGlam Laser System (SHE-LSP601-3)?

LumiGlam Laser System (SHE-LSP601-3) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K260690.

When did LumiGlam Laser System (SHE-LSP601-3) receive FDA 510(k) clearance?

LumiGlam Laser System (SHE-LSP601-3) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260690.

Who is the listed applicant for LumiGlam Laser System (SHE-LSP601-3)?

The FDA 510(k) record lists Beijing Sano Laser S&T Development Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumiGlam Laser System (SHE-LSP601-3)?

The FDA product code for LumiGlam Laser System (SHE-LSP601-3) is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Sano Laser S&T Development 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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