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FDA 510(k)

ILT SURGICAL LASER

K-Number: K954460 · 1995-12-18

ApplicantIon Laser Technology
Decision Date1995-12-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ILT SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Ion Laser Technology. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K954460. 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 ILT SURGICAL LASER?

ILT SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Ion Laser Technology. The 510(k) number is K954460.

When did ILT SURGICAL LASER receive FDA 510(k) clearance?

ILT SURGICAL LASER received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954460.

Who is the listed applicant for ILT SURGICAL LASER?

The FDA 510(k) record lists Ion Laser Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILT SURGICAL LASER?

The FDA product code for ILT SURGICAL LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Ion Laser Technology 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.

K974369APOLLO 9500K964524ILT ARGON HPK953898ACL-5500 PRECISION CURING UNIT (PCU)K950351CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)K944317GENESIS 2000K944206GENESIS 2000

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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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., 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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