FDA Recalls Zemits NDPrime Yag Laser for Missing Safety Interlocks
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. However, the hazard is significant—Class IV lasers can cause severe eye and skin damage, and the device lacks safety interlocks required to prevent exposure to laser radiation.
Plain-English summary
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser due to non-compliance with federal radiation safety regulations. The device is a Class IV laser system used for tattoo removal applications.
The manufacturer failed to comply with Electronic Product Radiation Control (EPRC) regulations and laser product performance standards. The devices are missing or require updates to critical safety components and labeling, including: remote interlock connectors, safety interlocks, manual reset mechanisms, beam attenuators, compliance certifications, and warning labels with Class IV laser designation.
The recalled product
- Product
- MED-810A Zemits NDPrime Laser products
- Manufacturer
- Advance-Esthetic LLC
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model MED-810A Zemits NDPrime Laser products
Distribution
Distributed nationwide across the United States.
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