Updated August 31, 2026
Hair is the one red light application with a genuine FDA clearance pathway, and the evidence rests on lasers rather than LEDs. That makes the laser-versus-LED split the single most important thing on a cap's spec sheet. One warning about the other number brands lead with: a cap advertising 1,360 mW of total output is quoting 272 diodes multiplied by a nominal 5 mW rating. It is arithmetic, not a measurement, which is why competing brands publish identical figures.
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The honest spec sheet pick: 80 lasers and no LEDs inflating the number. Uses 680nm, slightly deeper penetrating than the usual 650nm.
Laser diodes, not LEDs, which matters for hair: the clinical evidence for hair regrowth is built on low-level laser therapy specifically.
The lowest time commitment of the major caps at three 7 minute sessions a week. Note that many listings attribute clearance K213025 to this cap; that number belongs to a different applicant. Lexington International's HairMax Laser clearance on file is K180885.
Worth the upgrade only if you have a larger head or diffuse thinning across the whole scalp.
This is a transcranial device at 810nm, not a hair growth cap, despite the helmet form factor. Mito is unusually honest about its output, publishing the deflating spectroradiometer number next to the flattering one.
Sits between the entry iRestore and the Elite. The 1410 mW output figure is among the highest published in the category.
All 272 emitters are 650nm laser diodes, no LEDs, so the 272 figure really is 272 lasers. Cleared under Eglobal LLC as K162071 (IllumiFlow Laser Cap), with the 148 model cleared separately as K173843.
All 272 emitters are laser diodes, so this is a true 272-laser cap rather than a mixed laser and LED count. Capillus holds several clearances, with the 272 Pro covered by K143199 and later K163170.
Read the spec carefully: the 500 figure combines lasers and LEDs. Cheaper caps with fewer but all-laser diodes may deliver comparable therapeutic light.
40 laser diodes at 680nm plus or minus 3nm and zero LEDs, so a low count but every emitter is a laser. Cleared as K161046 (Laser Helmet LH40-EVO), with the related LH40 cleared as K180460.