Documentation that stays attached to the right model.

A buyer-facing view of the evidence currently available, the boundaries that matter and the questions resolved before production.

FDA 510(k)

M01 / M02 / M06 / M07 / M08 / M09

K251667. Other mask families are not represented as cleared under this submission.

4D family

QZ041-4D01…09

CE EMC/LVD, FCC Part 15B and RoHS documents available by exact model.

5D family

QZ049 / QZ042 / QZ041

CE EMC, FCC Part 15B and RoHS documentation; not interchangeable with QZ041-4D models.

Diamond family

MZ11…MZ20

CE EMC/LVD documents. No whole-device FCC or RoHS claim is made here.

Scalp light

QZ022 / QZ036

CE EMC/LVD, FCC Part 15B and RoHS documents subject to image/configuration matching.

Body light

QZUL051-1…5

Tested to UL 859 under ENC2601110GZ83U1; this is not a UL Listing.

Verification follows the configuration.

Our working rule is simple: model number, product image, electronics, battery and supplied documentation have to refer to the same product.

01Identify the exact model

No near-match assumptions between visually similar families.

02Lock the specification

Resolve conflicting light-source, LED-count, weight or battery fields before publication.

03Map whole-device evidence

Battery transport documents are not presented as whole-device CE, FCC or RoHS evidence.

04Review the market claim

Medical, cosmetic and performance language is evaluated separately for the target market.

Available by model. Confirmed by project.

Reports and certificates can be shared during qualified project review. Applicability is reconfirmed whenever the model, component set or intended market changes.

The information on this site is a sourcing overview, not legal or regulatory advice. Final claims and market access should be reviewed by the buyer’s qualified compliance team.

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