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FDA 510(k)

CANDELA H:ERB LASER

K-Number: K921995 · 1994-11-07

ApplicantCandela Laser Corp.
Decision Date1994-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA H:ERB LASER is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K921995. 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 CANDELA H:ERB LASER?

CANDELA H:ERB LASER is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Candela Laser Corp.. The 510(k) number is K921995.

When did CANDELA H:ERB LASER receive FDA 510(k) clearance?

CANDELA H:ERB LASER received FDA 510(k) clearance on 1994-11-07, under 510(k) number K921995.

Who is the listed applicant for CANDELA H:ERB LASER?

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

What is the FDA product code for CANDELA H:ERB LASER?

The FDA product code for CANDELA H:ERB LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Candela Laser Corp. 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.

K951033ANDELA DYNAMIC COOLING DEVICEK955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK955011CANDELA HCS 2000 URETHERAL WARMER CATHETERK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEM

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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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