510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913314Substantially Equivalent

Candela Retinal Camera

Candela Corporation, Wayland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913314 is the FDA 510(k) clearance record for CANDELA RETINAL CAMERA, a class II device, cleared for Candela Laser Corp. on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K913314.

Clearance record

Decision date
Received
(182 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Candela Laser Corp. 530 Boston Post Rd., Wayland MA
510(k) summary
Summary
Third party review
No

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260