Manufacturer
Speclipse, Inc.PICO SHINING (PICO-K; PICOFY)
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
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
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K261214 as a predicate