Class Class II
Heager Medical Laser Family (Sabrina/Adolf) (K250261)
Description
Heager Medical Laser Family (Sabrina/Adolf) by Heager GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250261
Clearance Date2025-08-26
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250261
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. Heager Medical Laser Family (Sabrina/Adolf) (K250261) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 |
| K212734 | Diode laser therapy device | Triangel Rsd Limited | 2023 |
| K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS | Photo Medex, Inc. | 2008 |
Trace the full predicate network for K250261
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.