Cleared Traditional

K913314 - CANDELA RETINAL CAMERA

K913314 is an FDA 510(k) clearance for CANDELA RETINAL CAMERA, manufactured by Candela Laser Corp.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K913314 · Candela Laser Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
182d
Days
Class 2
Risk

K913314 is an FDA 510(k) clearance for the CANDELA RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 182 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Candela Laser Corp. devices

FDA 510(k) Submission Details - K913314

510(k) Number K913314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date January 23, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 110d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 108
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K913314.
NON-MYDRIATIC RETINAL CAMERA
K941234 · Canon USA, Inc. · Jun 1995
60 FUNDUS CAMERA CF-60UV
K946058 · Canon USA, Inc. · Feb 1995
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · Canon USA, Inc. · Feb 1994
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · Canon USA, Inc. · Jun 1991
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · Canon USA, Inc. · Oct 1989
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · Canon USA, Inc. · Nov 1987