MED-810A Zemits NDPrime Laser products
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAShahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bags2024-05-21
- FDAprocedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿ 28-GG521, l)¿¿¿¿¿¿ 28-GG521PC, m)¿¿¿ 2...2023-07-07
- FDAProcedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT042023-07-07
- FDAASG-001; Ultrasound gel2023-07-07
- FDA50-GEL20; Ultrasound gel2023-07-07
- FDAProcedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC6482023-07-07
- FDAProcedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG1972023-07-07
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