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Freedom251 › Blog › FDA 510(k)

Kiierr vs. iRESTORE: Comparing the 272 and Professional 282 Hair-Growth Devices

By Freedom251 Team · · 3 min read

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Neither the Kiierr 272 nor the iRESTORE Professional 282 is proven superior to the other by the available evidence. The practical choice is between Kiierr’s laser-only cap, used for 30 minutes every other day, and iRESTORE’s laser-and-LED helmet, used for 25 minutes every other day. Compare the exact model’s labeled population, fit, comfort and routine you can maintain—not diode counts alone.

What the FDA records establish—and what they do not

The FDA’s 510(k) clearance is a regulatory finding tied to an intended use and a substantial-equivalence review. It is not the same as FDA approval, a promise of regrowth or proof that one cleared device works better than another.

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The FDA summary for Kiierr’s 272 and 148 devices states that no clinical performance data were produced for the Kiierr submission because the devices were the same as the predicate device. The summary for iRESTORE Professional 282 also describes a substantial-equivalence clearance, not a clinical comparison with Kiierr. The records therefore do not establish a brand-to-brand winner.

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See the FDA Kiierr 510(k) summary and the FDA iRESTORE Professional 282 summary.

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Kiierr 272 vs. iRESTORE Professional 282

Comparison Kiierr 272 iRESTORE Professional 282
Form Cap/helmet-style shell with a protective liner Helmet
Light sources in the FDA filing 272 laser diodes 82 laser diodes and 200 LEDs
Wavelength in the FDA summary 650 ± 5 nm 650 ± 10 nm
Session schedule in the FDA summary 30 minutes every other day on non-consecutive days for 16 weeks 25 minutes every other day on non-consecutive days for 16 weeks
Labeled population in the filing Men with Norwood-Hamilton IIa–V or women with Ludwig-Savin I–II, Fitzpatrick skin phototypes I–IV Men with Norwood-Hamilton IIa–V or women with Ludwig-Savin I–II, Fitzpatrick skin phototypes I–IV
Direct comparative evidence No Kiierr-specific clinical performance data in its 510(k) submission No head-to-head comparison with Kiierr in its 510(k) summary

These specifications come from the FDA filings, which concern the named models; they should not be assumed to describe other generations. Follow the current manual supplied with the exact device you buy if its instructions differ from the filing schedule.

How to choose between them

Choose by routine, not a five-minute difference alone

Both filings describe use every other day on non-consecutive days for an initial 16 weeks. Kiierr’s listed session is five minutes longer than iRESTORE Professional 282’s. That may matter if it affects whether you can stick to a routine, but the schedules do not establish which device produces better results.

Check fit and comfort before deciding

The Kiierr filing describes a shell with a liner; iRESTORE Professional 282 is described as a helmet. Fit and comfort are individual, and the regulatory summaries do not settle which one will feel better on your head. Review the fit information and return terms for the exact model before buying.

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Do not treat light-source counts as an efficacy ranking

Kiierr 272 lists 272 laser diodes; iRESTORE Professional 282 lists 82 laser diodes plus 200 LEDs. The different source configurations and counts describe device design, not comparative clinical benefit. iRESTORE’s Professional product page describes the model and its intended-use population. Its separate Elite page advertises 500 light sources and 2,500 mW; those are manufacturer claims for Elite, not independent evidence that it outperforms either model here.

Confirm the product generation and purchase terms

Compare the model name on the product page, manual and checkout listing. The Kiierr filing covers both the 272 and 148, while iRESTORE Professional 282 and Elite are distinct products; do not transfer a specification from one to another. Verify current price, warranty, returns and seller details directly before purchase, since the FDA records do not establish those terms.

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What the cited clinical evidence means

The original iRESTORE filing says its 25-minute, every-other-day, 16-week protocol was established through clinical testing with the predicate iGrow device. It identifies a male study published in Lasers in Surgery and Medicine 45:487–495 (2013) and a female study in volume 46:601–607 (2014). Those are predicate-device studies, not tests of iRESTORE against Kiierr. The FDA iRESTORE K151662 summary provides that regulatory history.

A 2021 systematic review examined randomized trials of FDA-cleared home-use low-level light therapy devices, but its study-level findings do not provide a direct Kiierr 272-versus-iRESTORE Professional 282 result. Do not use results from a different device or study as a brand comparison. Read the 2021 systematic review.

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Who should check the label—and when to seek medical advice

The cited filings describe use for androgenetic alopecia within the stated male and female hair-loss classifications and Fitzpatrick skin phototypes I–IV. If you fall outside those labeled groups, do not assume either device is indicated for you. These consumer devices do not diagnose why hair is falling out, cover every type of alopecia or guarantee an outcome.

Sudden, patchy, painful or otherwise unexplained hair loss warrants assessment by a healthcare professional before choosing a light-based consumer device. The available evidence does not support ranking Kiierr and iRESTORE by brand-specific adverse-event rates.

Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.

FDA 510(k)hair growth devicesiRESTOREKiierrlow-level light therapy

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