Data / Medical devices / South Korea / Speclipse, Inc.
Speclipse, Inc.: FDA-registered device maker in Ansan-si Gyeonggi, South Korea, 3 510(k) clearances
Speclipse, Inc. is registered with the FDA (registration 3013697074) in Ansan-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013697074
- Address
- #501, #502, #503, #504, #505, 232 Sandan-ro, Danwon-gu, Ansan-si Gyeonggi, South Korea, 15433
- Owner or operator
- SPECLIPSE, Inc. (10094634)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 11, 2025
- Registered through
- 2026
- Brand names listed
- BELLUS-Q, PICO-K, PICOFY, QMODE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 11, 2026 | K261214 | PICO SHINING (PICO-K; PICOFY) | GEX | Substantially Equivalent | Speclipse, Inc. | accessdata.fda.gov |
| December 24, 2025 | K253342 | PICO-K | GEX | Substantially Equivalent | Speclipse, Inc. | accessdata.fda.gov |
| November 25, 2025 | K253344 | BELLUS-Q | GEX | Substantially Equivalent | Speclipse, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.