FDA Inspection
SHENZHEN WISELY LASER MACHINERY CO., LIMITEDSHENZHEN WISELY LASER MACHINERY CO., LIMITED – FDA Inspection, Aug 24, 2026
Record Details
This FDA Inspection record concerns SHENZHEN WISELY LASER MACHINERY CO., LIMITED, with an inspection on August 24, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 24, 2026
- Product Type
- Medical Devices & Rad Health
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ID · fd2b6a1e-7362-4c51-9e81-1fc52a77f327
Inspection Facts
- Inspection number
- 1335552
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(1)Quality control procedures
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1040.10(f)(5)(ii)Emission indicator - Class IIIb & IV
- 21 CFR 1040.10(f)(6)(i)Beam attenuator
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
- 21 CFR 1040.10(h)(1)(ii)User information, radiation output information
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
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