# FDA WARNING_LETTER - Quanta Aesthetic Lasers USA, LLC - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/quanta-aesthetic-lasers-usa-llc/edf07831-f907-4690-b8ca-a54282d36232

> FDA WARNING_LETTER for Quanta Aesthetic Lasers USA, LLC on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Quanta Aesthetic Lasers USA, LLC
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On June 16, 2012, the FDA issued a Warning Letter to Quanta Aesthetic Lasers USA, LLC, regarding their Quanta System Q-Plus T device. The FDA's review of the firm's website, www.quantausa.com, revealed that the device was being marketed for unapproved indications and with unapproved modifications.

The Quanta System Q-Plus T (K073549) was cleared for specific indications including treatment of vascular lesions, pigmented lesions, hair and tattoo removal, and soft tissue incision/excision/ablation/vaporization using Nd:YAG (1064nm, 532nm) and Ruby (694nm) lasers.

However, the firm's website promoted the device for "skin rejuvenation," "skin lifting," "skin tightening/smoothness," "acne treatments," "anti-aging," "firming," and "treatment of scars and keloids." These claims represent a major change in intended use, potentially affecting safety and effectiveness. Consequently, the device is adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) for lacking required premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) (21 U

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/quanta-aesthetic-lasers-usa-llc/4ca58519-8f95-4b87-8577-7658c8e77bf2

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861