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FDA 510(k)

CANDELA RETINAL CAMERA

K-Number: K913314 · 1992-01-23

ApplicantCandela Laser Corp.
Decision Date1992-01-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANDELA RETINAL CAMERA 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 1992-01-23 under 510(k) number K913314. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA RETINAL CAMERA?

CANDELA RETINAL CAMERA is a medical device that received FDA 510(k) clearance on 1992-01-23. The listed applicant is Candela Laser Corp.. The 510(k) number is K913314.

When did CANDELA RETINAL CAMERA receive FDA 510(k) clearance?

CANDELA RETINAL CAMERA received FDA 510(k) clearance on 1992-01-23, under 510(k) number K913314.

Who is the listed applicant for CANDELA RETINAL CAMERA?

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 RETINAL CAMERA?

The FDA product code for CANDELA RETINAL CAMERA is HKI.

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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: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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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