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FDA 510(k)

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

K-Number: K242755 · 2025-05-19

ApplicantGigaalaser Company , Ltd.
Decision Date2025-05-19
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K242755. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Gigaalaser Company , Ltd.. The 510(k) number is K242755.

When did Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) receive FDA 510(k) clearance?

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) received FDA 510(k) clearance on 2025-05-19, under 510(k) number K242755.

Who is the listed applicant for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

The FDA 510(k) record lists Gigaalaser Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

The FDA product code for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is ILY.

Other records listing Gigaalaser Company , 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.

K250018Medical Diode Laser Systems (THEIA808)K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)K230047Medical Diode Laser Systems

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.K202028dermalux Flex MDAesthetic Technology, Ltd.

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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