Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 18, 2023
MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Advance-Esthetic LLC recalled MED-810A Zemits NDPrime Laser products - a moderate-severity action.
MED-810A Zemits NDPrime Laser products was recalled by Advance-Esthetic LLC in October 18, 2023. Reason: Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Co…. Check the official notice for the remedy. Verify recall #Z-0095-2024 with the FDA Devices before acting.
The recall
Advance-Esthetic LLC issued this moderate-severity FDA Devices recall-Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Co….
- Moderate
- severity level
- 19 units
- affected scope
- Class II
- classification
- October 18, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0095-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0095-2024) was formally reported on October 18, 2023, with the manufacturer initiating the action on October 9, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Advance-Esthetic LLC is listed as the recalling firm, operating out of Fort Lauderdale, FL. Federal records list the affected scope as 19.
The documented reason for this recall is: Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recal… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19
Related Recalls
6
3 from same agency
Product description
MED-810A Zemits NDPrime Laser products
Reason for recall
Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0095-2024 |
| Date reported | October 18, 2023 |
| Date initiated | October 9, 2023 |
| Recalling firm | Advance-Esthetic LLC |
| Firm location | Fort Lauderdale, FL |
| Affected scope | 19 |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0095-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
MED-810A Zemits NDPrime Laser products. Recalled by Advance-Esthetic LLC. Units affected: 19.
Why was this product recalled? ▼
Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0095-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0095-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 18, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.