Clear+brilliant Laser System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Clear+Brilliant® Laser System EUDAMED

Clear & Brilliant GUDID

Generic Name

Dermatological laser beam guiding handpiece

Device Name

Clear+Brilliant Permea Handpiece (1927 nm)

Model / Ref / Catalog

CB-HP-1927

Primary DI / UDI-DI

00850608002636

Basic UDI-DI

B-00850608002636

510(k) Number

K110349 ↗

FDA Product Code

ONG

EMDN Code

Z120615 Therapeutic lasers

GMDN Term

Dermatological laser beam guiding handpiece

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4810

Market of Registration

Netherlands

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

See all devices from Solta Medical, Inc. →

• What types of skin conditions is the ClearBrilliant Laser System primarily used to treat, and how does it work?

  The ClearBrilliant Laser System is designed for fractional resurfacing and tissue remodeling procedures to address skin conditions such as wrinkles, scars, and pigmentation irregularities. It achieves this by delivering controlled laser energy to create microscopic zones of thermal damage in the skin, promoting natural healing and rejuvenation. This fractional approach targets specific areas while leaving surrounding tissue intact, aiding in skin renewal.

• Is the ClearBrilliant Laser System intended for single-use or can it be reused after proper maintenance?

  The ClearBrilliant Laser System is supplied as a reusable medical instrument. It requires proper maintenance and sterilization per the manufacturer’s guidelines to ensure safety and performance for repeated clinical use. Reuse is only permissible when following the established protocols provided by Solta Medical, Inc.

• What regulatory pathways has the ClearBrilliant Laser System undergone, and how does this affect its use?

  The ClearBrilliant Laser System has undergone FDA 510(k) clearance and EU MDD compliance, confirming its substantial equivalence to existing devices in its category. This means it has been evaluated for safety and effectiveness by regulatory authorities and is intended for use in clinical settings by trained professionals, typically in plastic surgery or dermatology. The regulatory route ensures adherence to standards for powered laser surgical instruments with microbeam fractional output.

• Are there any specific storage requirements for the ClearBrilliant Laser System?

  The device data does not specify storage requirements, but as a reusable medical instrument, it should be stored in a clean, dry environment following manufacturer guidelines to maintain its functionality and sterility. Proper handling and maintenance are essential to ensure the system remains operational for clinical use.