# FDA 483 - Aerolase Corp. - August 08, 2019

Source: https://www.keypedia.com/records/483/aerolase-corp/2da05363-7fd8-44b3-824c-5188998354e4

> FDA 483 for Aerolase Corp. on August 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aerolase Corp.
- Inspection Date: 2019-08-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Aerolase Corporation, a manufacturer and importer of medical lasers in Tarrytown, NY, was cited for four observations during an FDA inspection. The inspection revealed deficiencies related to laser product safety features, inadequate operating instructions and hazard warnings, undeveloped Medical Device Reporting (MDR) procedures, and poorly maintained device history records. These issues indicate a need for improved compliance with regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2021-05-20](https://www.keypedia.com/records/483/aerolase-corp/55646690-8312-4fa0-b6cd-205b3408a0e6)

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)
- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/aerolase-corp/b6d48953-2385-4a88-b4cc-a8b8cb497479

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961