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FDA 510(k)

ALEX TA2 ERASER

K-Number: K980131 · 1998-02-17

ApplicantLight Age, Inc.
Decision Date1998-02-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALEX TA2 ERASER is the device name listed in this FDA 510(k) record. The listed applicant is Light Age, Inc.. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K980131. 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 ALEX TA2 ERASER?

ALEX TA2 ERASER is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Light Age, Inc.. The 510(k) number is K980131.

When did ALEX TA2 ERASER receive FDA 510(k) clearance?

ALEX TA2 ERASER received FDA 510(k) clearance on 1998-02-17, under 510(k) number K980131.

Who is the listed applicant for ALEX TA2 ERASER?

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

What is the FDA product code for ALEX TA2 ERASER?

The FDA product code for ALEX TA2 ERASER is GEX. This falls under the Gastroenterology category.

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Other records listing Light Age, 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.

K113115EPICARE YAGK110370Q-CLEARK091625EPICARE-DUO LASER SYSTEMK032991LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPXK033259LIGHT AGE Q-CLEAR LASER, MODEL 701-1101K983977LIGHT AGE EPICARE ALEXANDRITE LASER

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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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