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FDA 510(k)

SACS, INDEPENDENT FIBER COOLANT SYSTEM

K-Number: K952754 · 1995-07-31

ApplicantSurgical Laser Technologies, Inc.
Decision Date1995-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SACS, INDEPENDENT FIBER COOLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K952754. 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 SACS, INDEPENDENT FIBER COOLANT SYSTEM?

SACS, INDEPENDENT FIBER COOLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K952754.

When did SACS, INDEPENDENT FIBER COOLANT SYSTEM receive FDA 510(k) clearance?

SACS, INDEPENDENT FIBER COOLANT SYSTEM received FDA 510(k) clearance on 1995-07-31, under 510(k) number K952754.

Who is the listed applicant for SACS, INDEPENDENT FIBER COOLANT SYSTEM?

The FDA 510(k) record lists Surgical Laser Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SACS, INDEPENDENT FIBER COOLANT SYSTEM?

The FDA product code for SACS, INDEPENDENT FIBER COOLANT SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Surgical Laser Technologies, Inc. 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.

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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