FDA Inspection
Curae'Lase, Inc.Curae'Lase, Inc. – FDA Inspection, Apr 7, 2011
Record Details
This FDA Inspection record concerns Curae'Lase, Inc., with an inspection on April 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Curae'Lase, Inc.
- Inspection Date
- April 7, 2011
- Product Type
- Devices
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ID · 6424adfc-861e-4b54-8b25-4dfc8b3692d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 718668
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.181(a)DMR device specifications
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Other FDA inspections of Curae'Lase, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Curae'Lase, Inc.
- FDA Inspection 1048581 - 2018-02-05
- FDA Inspection 811634 - 2012-11-06
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