Hollywood Spectra Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213569 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hollywood Spectra Laser System is a dual-wavelength laser system designed for treating a variety of skin concerns with minimal downtime. It uses short-pulsed laser energy to break down pigmentation, stimulate collagen, and improve skin tone and texture.
The device is supplied as a laser system for use in clinical settings such as general and plastic surgery practices. It received FDA 510(k) clearance (K213569) on February 4, 2022, and is classified under product code GEX. The system is intended for non-contact energy delivery via a collimated handpiece and is authorized for sale in the United States.
Frequently asked questions
What is the Hollywood Spectra Laser System used for?
The Hollywood Spectra Laser System is designed for treating various skin concerns with minimal downtime. It uses short-pulsed laser energy to break down pigmentation, stimulate collagen, and improve skin tone and texture.
How is the Hollywood Spectra Laser System supplied?
The device is supplied as a complete laser system intended for use in clinical settings such as general and plastic surgery practices. It features non-contact energy delivery via a collimated handpiece.
What is the regulatory status of the Hollywood Spectra Laser System?
The Hollywood Spectra Laser System received FDA 510(k) clearance (K213569) on February 4, 2022, and is classified under product code GEX. It is authorized for sale in the United States.
Is the Hollywood Spectra Laser System reusable or single-use?
The device is a laser system designed for multiple treatments in clinical settings. The handpiece is used for non-contact energy delivery, but the system itself is intended for repeated use in professional medical environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hollywood Spectra Pigment Laser - Cynosure Lutronic, Hollywood Spectra - Cynosure Lutronic EMEA Hollywood Spectra | Cynosure ..., Hollywood Spectra - Cynosure Lutronic APAC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213569 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K213569 24 fields · synced Sep 24, 2026