← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HQF — Laser, Ophthalmic

DEVICE CLASS
Class II
REGULATION
21 CFR 886.4390
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K252979Belkin Vision, Ltd. · 510k2026-04-07
K251507Quantel Medical · 510k2026-02-06
K251772Od-Os GmbH · 510k2025-10-29
K243014Eyeq, Inc. · 510k2025-06-18
K240615Beaver-Visitec International, Inc. · 510k2025-04-03
K242397Norlase Aps · 510k2024-10-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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