iRestore Essential vs Elite vs Professional
Last checked 2026-10-02.
All three iRestore helmets have their own 510(k): the Essential K213094, the Professional K183417 and the Elite K222081, all held by Freedom Laser Therapy, Inc., and none of the three clearances cites clinical data of its own: each was cleared as equivalent to an earlier device. They differ in light sources (120 lasers and LEDs (iRestore's count); the summary gives 655 nm, laser and LED; 82 lasers and 200 LEDs (510(k) summary); 300 lasers and 200 LEDs (510(k) summary)) and in session length and schedule, as below.
What these devices are cleared for. The FDA cleared them (product code OAP, 21 CFR 890.5500) to promote hair growth in androgenetic alopecia (pattern hair loss): in men with Norwood-Hamilton classifications IIa to V, and in women with Ludwig-Savin classifications I to II (some clearances add frontal patterns), and for both only in Fitzpatrick skin phototypes I to IV, per the Indications for Use in each device's 510(k) summary. They are not cleared for other kinds of hair loss, such as alopecia areata, telogen effluvium or scarring alopecia; Fitzpatrick skin phototypes V and VI; hair loss beyond Norwood-Hamilton V or Ludwig-Savin II. A 510(k) clearance is a substantial-equivalence review, not FDA approval and not proof that a device works for you.
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Side by side
| Essential | Professional | Elite | |
|---|---|---|---|
| Model | ID-500 | Professional 282 | ID-510 |
| 510(k) | K213094 “ID-500 iRestore Hair Growth System”, held by Freedom Laser Therapy, Inc., decided 2021-12-22 (summary) | K183417 “iRestore Professional 282”, held by Freedom Laser Therapy, Inc., decided 2019-05-17 (summary) | K222081 “ID-510 iRestore Elite”, held by Freedom Laser Therapy, Inc., decided 2022-10-13 (summary) |
| Clinical data in its own 510(k) | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only | No: cleared as similar to the earlier iRestore Hair Growth System (K151662), without its own clinical data | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only |
| Light sources | 120 lasers and LEDs (iRestore's count); the summary gives 655 nm, laser and LED | 82 lasers and 200 LEDs (510(k) summary) | 300 lasers and 200 LEDs (510(k) summary) |
| Wavelength | 655 nm | 650 nm | 680 nm lasers; 625 and 655 nm LEDs |
| Session | 25 minutes; schedule not stated in the sources read | 25 minutes, every other day, for 16 weeks (510(k) summary); the Amazon listing says 2 to 3 times a week | 12 minutes, daily (510(k) summary and Amazon listing) |
| Power | AC powered (510(k) summary) | plugged in; a battery pack is sold separately (Amazon listing) | not stated in the sources read |
| Warranty | not stated in the sources read | not stated in the sources read | not stated in the sources read |
| Seller | iRESTORE, shipped by Amazon | iRESTORE, shipped by Amazon | iRESTORE, shipped by Amazon |
| Sources | iRestore's device list, irestorelaser.com; Amazon listing (session length) | iRestore's device list, irestorelaser.com; Amazon listing | iRestore's device list, irestorelaser.com; Amazon listing |
| Buy | Amazon → | Amazon → | Amazon → |
Kinds of claim on this page: 510(k) numbers, holders, dates, indications and whether a clearance cites clinical data are product evidence from the FDA database; trial results are technology research about low-level laser devices in general, cited to each study, never evidence for one model; session times, schedules, power and warranty are manufacturer claims from each maker's page or the Amazon listing. All read 2026-10-02. Anything no source states is marked as not stated. No prices are shown: check the retailer for the current price.
What the table does and does not tell you
More light sources is not shown here to mean more hair: no trial read for this page compares these three models with each other. What sham-controlled trials of the kind of device found is on what the trials show. A comb or another helmet: cap, comb or helmet.
The Elite's K222081 is also listed, with its holder, beside other brands' caps under product code OAP in LEDMaskScore's record of laser-cap clearances.
We tested nothing. This page gives no medical advice and makes no promise of results.