FDA Inspection
Summus Medical Laser LLCSummus Medical Laser LLC – FDA Inspection, Apr 18, 2013
Record Details
This FDA Inspection record concerns Summus Medical Laser LLC, with an inspection on April 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Summus Medical Laser LLC
- Inspection Date
- April 18, 2013
- Product Type
- Devices
View Company Profile
ID · 5324a575-78f0-401a-a524-c458f6c5badc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835348
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 1040.10(g)(5)(ii)Aperture label wording - collateral EM radiation
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
- 21 CFR 820.72(b)Remedial action
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