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FDA 510(k)

CANDELA CRYOSYSTEM CS-5

K-Number: K953294 · 1995-10-18

ApplicantCandela Laser Corp.
Decision Date1995-10-18
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA CRYOSYSTEM CS-5 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 1995-10-18 under 510(k) number K953294. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA CRYOSYSTEM CS-5?

CANDELA CRYOSYSTEM CS-5 is a medical device that received FDA 510(k) clearance on 1995-10-18. The listed applicant is Candela Laser Corp.. The 510(k) number is K953294.

When did CANDELA CRYOSYSTEM CS-5 receive FDA 510(k) clearance?

CANDELA CRYOSYSTEM CS-5 received FDA 510(k) clearance on 1995-10-18, under 510(k) number K953294.

Who is the listed applicant for CANDELA CRYOSYSTEM CS-5?

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 CRYOSYSTEM CS-5?

The FDA product code for CANDELA CRYOSYSTEM CS-5 is GEH.

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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: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , 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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