Speclipse, Inc.

Country / region:Korea, Republic of (KR)

510(k) submissions

Latest clearance

2026-05-11

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

3 total

K number	Device name	Product code	Class	Decision date
K261214	PICO SHINING (PICO-K; PICOFY)	GEX	Class 2	2026-05-11
K253342	PICO-K	GEX	Class 2	2025-12-24
K253344	BELLUS-Q	GEX	Class 2	2025-11-25

Speclipse, Inc. references 4 predicate/reference devices

No later 510(k)s cite this device yet

Other submissions will appear here when they list Speclipse, Inc. as a predicate