K-number	K243014
Device name	EyeQ nanoECP
Applicant	Eyeq, Inc.
Product code	HQF
Device class	Class II
Decision date	Jun 18, 2025
Decision	Substantially Equivalent
Regulation	886.4390

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The EyeQ nanoECP System is an ophthalmic laser device designed for intraoperative photocoagulation of the ciliary processes to treat glaucoma in patients who have failed conventional medications, previous laser treatments, or surgical procedures. It is also used for evaluating internal ocular structures in patients with dense anterior segment opacifications that prevent posterior visualization.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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EyeQ nanoECP

Everything you need for a 510(k) submission. Nothing you don't.