Class Class II
HELIOS 785 Pico (K230373)
Description
HELIOS 785 Pico by Laseroptek Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230373
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230373
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HELIOS 785 Pico (K230373) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212663 | HELIOS IV 785 | Laseroptek Co., Ltd. | 2022 |
| K191685 | PicoWay Laser System | Candela Corporation | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 |
| K240752 | DEKA TORO | El.En S.P.A. | 2024 |
Trace the full predicate network for K230373
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.