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FDA 510(k)

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

K-Number: K222485 · 2023-03-29

ApplicantIds, Limited
Decision Date2023-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is a medical device manufactured by Ids, Limited. It received FDA 510(k) clearance on 2023-03-29 under approval number K222485. 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 SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by Ids, Limited. The 510(k) number is K222485.

When was SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser approved by the FDA?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser received FDA 510(k) clearance on 2023-03-29, under approval number K222485.

What company makes SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is manufactured by Ids, Limited.

What is the FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07599709 LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARS COMPLETED NCT07557524 Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers NOT_YET_RECRUITING NCT06960447 Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa NOT_YET_RECRUITING NCT07516106 Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access Sheaths NOT_YET_RECRUITING NCT05036200 Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma COMPLETED

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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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