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FDA 510(k)

ANDELA DYNAMIC COOLING DEVICE

K-Number: K951033 · 1996-08-15

ApplicantCandela Laser Corp.
Decision Date1996-08-15
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANDELA DYNAMIC COOLING DEVICE 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 1996-08-15 under 510(k) number K951033. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDELA DYNAMIC COOLING DEVICE?

ANDELA DYNAMIC COOLING DEVICE is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Candela Laser Corp.. The 510(k) number is K951033.

When did ANDELA DYNAMIC COOLING DEVICE receive FDA 510(k) clearance?

ANDELA DYNAMIC COOLING DEVICE received FDA 510(k) clearance on 1996-08-15, under 510(k) number K951033.

Who is the listed applicant for ANDELA DYNAMIC COOLING DEVICE?

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 ANDELA DYNAMIC COOLING DEVICE?

The FDA product code for ANDELA DYNAMIC COOLING DEVICE is IMD.

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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.

K955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK955011CANDELA HCS 2000 URETHERAL WARMER CATHETERK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEMK953294CANDELA CRYOSYSTEM CS-5

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Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.

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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