# FDA 483 - IPG Medical Corporation - November 04, 2025

Source: https://www.globalkeysolutions.net/records/483/ipg-medical-corporation/9b002f70-3484-47ef-a81b-4711ceeafb87

> FDA 483 for IPG Medical Corporation on November 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IPG Medical Corporation
- Inspection Date: 2025-11-04
- Product Type: device
- Office Name: New England District Office
- Summary: IPG Medical Corporation in Marlborough, MA, was inspected by the FDA from October 29 to November 4, 2025. The inspection revealed a significant safety concern regarding their Class 4 Thuvera Laser System, which lacked a required removable key to prevent unauthorized operation. This indicates a potential risk related to laser product safety controls.

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/ipg-medical-corporation/e2c02f89-17de-4466-8f44-921d10faa9e7

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144