# Speclipse, Inc.

- Location (FDA's records): Gyeonggi-Do, KR
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: GEX (3)
- 510(k) review time since 2016: median 56 days, against 90 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fotona D.O.O.: 2 (https://510kreport.com/company/fotona-doo)
- Hironic Co., Ltd.: 1 (https://510kreport.com/company/hironic)
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)

## Its most-cited devices
- K253342: PICO-K (2025), cited by 1

## Recent decisions
- K261214: Pico Shining (Pico-K; Picofy) (May 11, 2026)
- K253342: PICO-K (Dec 24, 2025)
- K253344: Bellus-Q (Nov 25, 2025)

Source page: https://510kreport.com/company/speclipse