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FDA 510(k)

MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR

K-Number: K895837 · 1989-12-14

ApplicantMedical Laser, Inc.
Decision Date1989-12-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser, Inc.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K895837. 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 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR?

MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Medical Laser, Inc.. The 510(k) number is K895837.

When did MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR receive FDA 510(k) clearance?

MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895837.

Who is the listed applicant for MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR?

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

What is the FDA product code for MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR?

The FDA product code for MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR is GEX. This falls under the Gastroenterology category.

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Other records listing Medical Laser, 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.

K913136LASER ENDOSCOPE DISC DECOMPRESSION KITSK912265MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200K912089MODIFIED SERIES 2100 ENDOSCOPESK901464MEDILASE SERIES 2200 ENDOSCOPEK900894MEDILASE SERIES 2100 ENDOSCOPE

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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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