# K080248: Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Apr 23, 2008 after 83 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
No predicates in its family tree.
96 later devices descend from it; 2 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lutronic Corporation Spectra VRMII Q-Switched Nd:YAG Laser System: named in the summary without a submission number
- (no number) HOYA ConBio MedLite C6 Laser System: named in the summary without a submission number
- (no number) RevLite Laser System: named in the summary without a submission number

## Most influential descendants
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), 57 descendants of its own
- K143105: Picosure Workstation (2015), 49 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own

## Indications for use
The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces): o Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) o Removal of Epidermal Pigmented Lesions o Removal of Minor Vascular Lesions including but not limited to telangiectasias o Treatment of Lentigines o Treatment of Caf6-Au-Lait o Treatment of Seborrheic Keratoses o Treatment of Post Inflammatory Hyper-Pigmentation o Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: o Tattoo removal: dark ink (black, blue and brown) o Removal of Nevus of Ota o Removal or lightening of unwanted hair with or without adjuvant preparation. o Treatment of Common Nevi o Skin resurfacing procedures for the treatment of acne scars and wrinkles

Source page: https://510kreport.com/device/K080248
Methodology: https://510kreport.com/methodology