Clinical Guide – all fields
Page A-1
Appendix B
CLINICAL GUIDE – ALL FIELDS
B.1 Overview
This chapter is provided to aid professionals in the use of the Opus System. Personnel operating the
system must have a thorough understanding of its proper operation.
This chapter has been prepared to aid medical personnel to understand the intended use, indications,
contraindications and adverse events relating to use. The information presented in this chapter is
necessary to reduce the risk of injury. Do not operate the system before reading this manual and gaining
a clear understanding of system, applicator operation and the clinical information gathered in this
chapter. If any part of this manual is not clear, contact your Alma Lasers representative for clarification.
Contact your Alma Lasers representative for current information on available training.
B.2 Intended and Indications for use
The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite and Opus] is intended
for use in dermatologic and general surgical procedures.
The Opus Plasma Applicator and Tips
The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for
dermatological procedures requiring ablation and resurfacing of the skin.
The Opus Colibri Applicator and Tips
The Opus Colibri Tips, when used with the unipolar Opus Colibri applicator, are indicated for
dermatological procedures requiring resurfacing of the skin.
B.3 Intended Patient Population
The intended patient population consists of adults greater than 21 years of age, both males and females
of all ethnic groups.
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