# K051876: Multiwave XR

- Pathway: 510(k) (Abbreviated)
- Applicant: Pacific Quantum Instruments, Inc.
- Decided: Sep 9, 2005 after 60 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910422 (1992). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag, Candela Corp. (2003) Summary page 1.
- K023193: Candela Gentle Yag Laser System, Candela Corp. (2002) Summary page 1.
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 1.
- K034011: Gemini Surgical Laser System & Accessories, Laserscope (2004) Summary page 1.
- K024206: Aura Isurgical Laser System & Accessories, Laserscope (2003) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.
- K032218: Adept 1064/532/755 Laser, Adept Medical Concepts (2003) Summary page 1.

## Indications for use
The MultiWave AR Laser System is indicated for the following uses: 1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face. 2. The 755 mm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for T-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 3. The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.

Source page: https://510kreport.com/device/K051876
Methodology: https://510kreport.com/methodology