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PICO SHINING (PICO-K; PICOFY)

Speclipse, Inc.

Country / region:Korea, Republic of (KR)Submission type:Special

Product code GEX· 21 CFR 878.4810

Company

Speclipse, Inc.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K261214
Device name
PICO SHINING (PICO-K; PICOFY)
Company
Speclipse, Inc.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2026-04-14
Decision date
2026-05-11
Submission type
Special
Technology type
Picosecond(unclassified)
Clinical applications
Pigment treatmentSkin resurfacing
Primary application
Pigment treatment
Classification source
AI classified

Predicate devices

0

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Cited as predicate

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