Dalphene Index

Devices linked to hair growth

Derived area

3 products · matched by keyword rule, not the cleared indication

Filters

Category

FDA pathwayCleared vs approvedCleared means the FDA agreed a device resembles one already on sale, while approved means the FDA read the maker's own clinical evidence and accepted it, so the two words describe different amounts of review and are not interchangeable.510(k) = cleared

Manufacturer2

Evidenceper modality

EU registerpresence only

Narrows to products we matched in EUDAMED. There is no opposite filter.

3 products

Maker · Injectables

No US authorization
DecisionStudies2,396Trials79

Biophotas, Inc. · Lasers & Light

510(k) · clearedClass IIK232977EU
Cleared2014StudiesTrials

SUN PHARM · Skin & Topicals

NDA · approvedNDA213433
Approved2020Studies90Trials21

Curated seed list; study and trial counts are per modality, not per brand.

Sorted by most recent FDA decision — a filing date, not a quality signal.

How each product matched (3)
ProductMatched termSource string
ASCE+alopeciaClinicalTrials.gov condition query for Exosome / extracellular-vesicle preparation
Cellumacomb, hairFDA product code OAP — Laser, Comb, Hair
WinlevialopeciaClinicalTrials.gov condition query for Topical clascoterone

Derived by keyword rule from real source strings, not the cleared indication.