FDA Inspection
LaserSight Technologies, Inc.LaserSight Technologies, Inc. – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns LaserSight Technologies, Inc., with an inspection on February 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 2, 2012
- Product Type
- Devices
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ID · b446e9e4-b92d-4182-9b4a-2adc7d150b78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765704
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
5- 21 CFR 1040.10(h)(1)(i)User information, adequate instructions
- 21 CFR 1040.10(f)(2)(iii)(a)No multiple safety interlock
- 21 CFR 1040.10(f)(3)Remote interlock connector
- 21 CFR 1040.11(b)Surveying, leveling, alignment laser products
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
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Other FDA inspections of LaserSight Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 21, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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