MZ Skin LightMax SuperCharged LED 2.0 Mask Review

What We Liked

• FDA 510(k) K213184 names this exact device, by name, for its indications - confirmed by reading the filing’s own indications-for-use section directly, not just a product-code match (see Quick Answer and FDA Registry Check below)
• Three wavelength types in one device (red, near-infrared, blue) - only iRestore Illumina also covers all three in this catalog
• 10-minute auto-shutoff, controlled by the device’s own timer and software, per the filing
• Full face coverage with built-in eye protection, per mzskin.com
• The predicate devices cited in its own clearance (Omnilux CLEAR, faceLITE) are both well-documented, giving this filing an unusually traceable substantial-equivalence record for this catalog

What We Didn’t Like

• The entity actually responsible for the device beyond Mz Skin (the applicant of record) is unclear - “I-SMART” appears spelled four different ways across the correspondent, GUDID labeler, and Registration & Listing establishment on this filing, plus the applicant of a predicate device it cites (see FAQ)
• Anti-Ageing mode frequency is stated three different ways across the brand’s own materials, not resolved here (see FAQ)
• Blue wavelength conflicts with itself within the same filing, not resolved here (see FDA Registry Check)
• No warranty term found on mzskin.com or anywhere else we checked

Who It Suits

• Anyone who wants a documented, device-named FDA indications statement backing both acne and anti-aging claims, not just a shared product-code definition
• Anyone who wants three wavelength types (red, NIR, blue) in a single mask
• Anyone comfortable cross-checking a usage schedule themselves rather than following one printed number, given the frequency conflict above

Who Should Choose Something Else

• Want a flexible silicone mask cleared under its own name → CurrentBody Series 2
• Want FSA/HSA eligibility stated directly on the listing → Dr. Dennis Gross DRx, whose specs state it; MZ Skin’s materials don’t mention FSA/HSA either way
• Want the lowest price tier in this catalog → iRestore Illumina

How It Works

Per K213184’s own device description: the system is a flexible silicone mask containing the LEDs, connected to a separate handheld controller. Pressing and holding one of two buttons selects a mode - Anti-Ageing (red + near-infrared) or Anti-Blemish (red + blue) - and starts a 10-minute countdown; the session stops automatically at zero, or earlier if the user presses the button again. The filing describes the underlying mechanism in two different terms depending on mode: “Photobiomodulation” for the wrinkle mode, “endogenous Photodynamic therapy” for the acne mode. The mask itself has no sensors and makes no measurements - per the filing, “the equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat.”

MZ Skin vs. Its Own Cited Predicates

K213184 names two predicate devices to establish substantial equivalence - both already relevant to this catalog. faceLITE (K191629) is the same clearance our Omnilux Contour Face review traces back to, though Omnilux Contour Face is a different product from Omnilux CLEAR, the other predicate cited here. Figures below are all from K213184’s own comparison table (section 5.4), not manufacturer marketing copy.

The filing states MZ Skin’s acne-mode output is identical to Omnilux CLEAR’s, and its wrinkle-mode output is similar to faceLITE’s - that identity/similarity claim is what the 510(k) uses to argue substantial equivalence, not an independent measurement of the retail device.

FDA Registry Check

K213184’s own indications-for-use section (5.2) states:

“The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.”

“The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.”

(The filing itself spells the device name “LightMAX Supercharged” - this review otherwise uses the spelling from mzskin.com and the product listing, “LightMax SuperCharged.”)

Both sentences name the device directly - not a product-code definition that happens to apply to a category of devices, and not a clearance traced under someone else’s brand name. This device’s indication text comes from the filing itself, read directly. Shark CryoGlow also has quoted indication text, sourced from GUDID’s summary field rather than its own filing. The remaining eleven devices in this catalog carry an acne- or wrinkle-related product code (OLP or OHS) but no indication text captured from either source yet - see the clearance check for what’s been verified for each.

Two things in the same filing don’t resolve as cleanly. First, section 5.1 (Device Description) states the blue wavelength as 412.5nm ± 7.5nm; section 5.4 (Comparison Characteristics), two pages later in the same document, states it as 415nm ± 10nm - the figure mzskin.com and our own catalog listing also use. Second, the same filing’s red wavelength is stated as 630nm ± 10nm throughout, while mzskin.com and our catalog listing both say 633nm - a gap between the filing and every marketing source, not an internal one this time. Neither is fixed here; both are shown as found.

The 510(k) applicant is Mz Skin itself (London, UK) - unusual in this catalog, where most retail brands trace to a separate OEM. Everyone else tied to this device or its own cited predicate goes by some version of “I-SMART” instead, spelled four different ways - see the FAQ below for all four. One of those four, I-SMART Development LTD. (registration number 3013481783), is the Registration & Listing establishment whose own entry pairs both product codes - “Over-The-Counter Powered Light Based Laser For Acne” (OLP) and “Light Based Over The Counter Wrinkle Reduction” (OHS) - directly with this device’s name. That pairing is the establishment’s own self-declaration in a federal database, not an FDA-verified fact; it corroborates the filing’s own indications-for-use text without adding independent weight to it. Checked Aug 18, 2026; see our full clearance check for the searches run across all 13 devices in this catalog.