Olo

The Olo is a laser surgical instrument that emits green laser radiation at 532 nanometers wavelength. It is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues, delivered through a fiber optic system with a handpiece or scanner.

The Olo is a diode laser (versus the predicate's diode-pumped solid state laser) operating at 532 nm with 8W maximum power, 5-90 ms pulse duration, and 10 Hz repetition rate. It uses internal water cooling instead of air cooling and offers spot diameters of 1-1.5 mm via handpiece or 1 mm via scanner. These specifications represent a subset of the predicate's capabilities, which also included a 577 nm wavelength option.

Electrical safety and electromagnetic compatibility testing per ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. Software verification and validation testing conducted per FDA's guidance on device software functions.

The Olo achieves substantial equivalence by performing an identical function (vaporization and photocoagulation of benign vascular and pigmented lesions) with substantially similar operational parameters. The proposed device's 532 nm wavelength, power output, energy range, and delivery mechanism are either identical or represent restricted subsets of the predicate's 532/577 nm dual-wavelength system. The narrower operating parameters (lower repetition rate, narrower pulse range) and different cooling approach do not introduce new safety or efficacy concerns and remain within established therapeutic parameters for this device category.