# K073436: Spectra Vrmii 1-Switched ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Dec 28, 2007 after 22 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Spectra QT Q-switched Nd:YAG Laser System: named in the summary without a submission number
- (no number) Tissue Medical Spectra-VRM Q-switched Nd:YAG Laser System: named in the summary without a submission number
- (no number) Altus Medical CoolGlide Aesthetic Lasers: named in the summary without a submission number
- (no number) Fotona QX Nd:YAG/KTP Laser System: named in the summary without a submission number
- (no number) NaturaLase LP with 532 Hand Piece: named in the summary without a submission number

## Most influential descendants
- K102050: Q-Switched ND:Yag Laser System, Model Globalcure-SC6 (2010), 0 descendants of its own

## Indications for use
The Spectra VRMII Laser System in indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. * 532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf&-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

Source page: https://510kreport.com/device/K073436
Methodology: https://510kreport.com/methodology