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FDA 510(k)

LIGHT-SPOT FIBEROPTIC LASER HANDPIECE

K-Number: K873664 · 1987-11-06

ApplicantLaserguide
Decision Date1987-11-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT-SPOT FIBEROPTIC LASER HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Laserguide. It received FDA 510(k) clearance on 1987-11-06 under 510(k) number K873664. 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 LIGHT-SPOT FIBEROPTIC LASER HANDPIECE?

LIGHT-SPOT FIBEROPTIC LASER HANDPIECE is a medical device that received FDA 510(k) clearance on 1987-11-06. The listed applicant is Laserguide. The 510(k) number is K873664.

When did LIGHT-SPOT FIBEROPTIC LASER HANDPIECE receive FDA 510(k) clearance?

LIGHT-SPOT FIBEROPTIC LASER HANDPIECE received FDA 510(k) clearance on 1987-11-06, under 510(k) number K873664.

Who is the listed applicant for LIGHT-SPOT FIBEROPTIC LASER HANDPIECE?

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

What is the FDA product code for LIGHT-SPOT FIBEROPTIC LASER HANDPIECE?

The FDA product code for LIGHT-SPOT FIBEROPTIC LASER HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Laserguide 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.

K880071SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USEK875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USEK873892SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USEK873571LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE

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

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

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