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FDA 510(k)

FOTONA NOVALIS ER: YAG LASER SYSTEM

K-Number: K991632 · 1999-08-10

ApplicantFotona D.D.
Decision Date1999-08-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOTONA NOVALIS ER: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.D.. It received FDA 510(k) clearance on 1999-08-10 under 510(k) number K991632. 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 FOTONA NOVALIS ER: YAG LASER SYSTEM?

FOTONA NOVALIS ER: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Fotona D.D.. The 510(k) number is K991632.

When did FOTONA NOVALIS ER: YAG LASER SYSTEM receive FDA 510(k) clearance?

FOTONA NOVALIS ER: YAG LASER SYSTEM received FDA 510(k) clearance on 1999-08-10, under 510(k) number K991632.

Who is the listed applicant for FOTONA NOVALIS ER: YAG LASER SYSTEM?

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

What is the FDA product code for FOTONA NOVALIS ER: YAG LASER SYSTEM?

The FDA product code for FOTONA NOVALIS ER: YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Fotona D.D. 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.

K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-NK113702FOTONA XP ND: YAG LASER SYSTEMK101306SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2AK101817LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-NK093162FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FIDK090126FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,

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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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