Fraxel Product Brochure

DUAL

DUAL

DUAL

DUAL

DUAL DUAL

Introducing the Fraxel® D UA L 1550/1927 System

INDICATION The Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927 Laser Systems are cleared for the following indications for use: o o Fraxel 1550nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; skin resurfacing procedures; treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos, solar lentigos, actinic keratosis, and melasma; and treatment of periorbital wrinkles, acne scars, and surgical scars. o o Fraxel 1927nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; treatment of actinic keratosis; treatment of pigmented lesions, specifically age spots, sun spots, and ephiledes.

IMPORTANT SAFETY INFORMATION • The following is a summary of contraindications for Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems treatments. Pre-screening should include, but not be limited to: o o Predisposition to keloid formation or excessive scarring; o o Pigmentation changes following surgery; o o Skin indentations and textural changes following surgery; o o Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; and o o Patients undergoing isotretinoin acne treatment or with drugs in a similar class.

• Do not use Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927on any patient who is ineligible for general surgery.

• The Fraxel 1550, Fraxel 1927 and Fraxel 1550/1927 DUAL generate a Class 4 laser. Protective eyewear or goggles should be worn by any operator and assistant.

Improper use of Fraxel may cause personal injury or damage to the system. See the Operator Manual for detailed directions, proper use, and full risk and safety information. For additional product information see www.fraxel.com.

REFERENCES 1. Laubach. Skin Responses to Fractional Photothermolysis. Lasers Surg Med 2006 38(2) 142-9.

2. White Paper. Solta Medical Initial Clinical Results with the New 1927nm Wavelength. 2009.

The power of two Addressing both deep and superficial resurfacing indications with powerful efficacy and consistency for all skin types anywhere on the body.

BEFORE

1 MONTH POST 2 TREATMENTS

BEFORE ENHANCED UV IMAGING

1 MONTH POST 2 TREATMENTS

BEFORE

3 MONTHS POST 1 TREATMENT

BEFORE 1 MONTHS POST 2 TREATMENTS Photographs Courtesy of Solta Medical Aesthetic Center

Before and after photos have not been retouched. Individual results may vary.

Deliver optimal results with less downtime than a superficial ablative treatment1 We’ve taken the industry leading non-ablative Fraxel re:storeŽ system to another level by adding a wavelength to better address pigmentation and other shallow indications on the entire body with minimal treatment discomfort when used as directed with topical numbing agents2.

With the touch of a button, select either the deep penetrating Erbium fiber laser (1550 nm) or the more superficial Thulium fiber laser (1927 nm). This is the first application of the Thulium wavelength in the aesthetic market and represents our commitment to developing innovative leading edge technology.

FraxelÂŽ DUAL 1550/1927 System benefits:*

Also incorporates all the benefits of Fraxel lasers:

Address both deep and superficial resurfacing: First system to feature dual fiber laser technology.

Predictable results: Patented continuous motion tracking system delivers uniform treatment with consistent results.

Accelerated clearance of pigment: Thulium wavelength more effectively targets superficial skin layers.

More comfortable procedure: Superficial targeting of the Thulium wavelength and focal cooling improves patient comfort2.

Faster treatment times: Improved scanner design increases procedure speed by 25%.

Simple to use: Intelligent touchscreen interface and precise dosimetry allows physician to easily select the optimal treatment settings.

Treatment versatility: Treatment of a variety of conditions on all skin types anywhere on the body.

*All improvements are as compared to the original Fraxel System.

PROVE N TE CHNOLOGY FROM A TRU ST E D NAME IN AE STHE TICS

Er:fiber (1550 nm) vs. Tm:fiber (1927 nm) Lesion Depth 1500

Lesion Depth (um)

The benefits of having an authentic Fraxel system in your practice:

Er:fiber 1550 nm

1250

Clinically proven: More than 50 peer-reviewed publications, supported by numerous histology slides.

1000

750

Effective: 10 years of experience with over half a million procedures worldwide.

500

Practice support: Ongoing clinical and practice management support from our extensively trained representatives.

250 Tm:fiber 1927 nm 0 0

10

20

30

40

50

Pulse Energy (mJ)

60

70

80

Brand recognition: Patients ask for Fraxel by name.

H I S TOLOGY C OM PA R I S ON – 20 m J

1550 nm

1927 nm

H&E staining illustrating non-ablative deep treatment with the 1550 nm Erbium fiber laser and non-ablative superficial resurfacing with the 1927 nm Thulium fiber laser

FRAXE L ® DUAL 1550/1927 FE ATU RE S & BE NE FITS* C ONT I NU OU S M OT I ON H A NDP I E C E Lightweight, ergonomic handpiece with single operator cooling that helps the laser create a consistent treatment zone pattern.

F R A X E L R OLLE R T I P S Cool roller tips allow focal cooling of target treatment sites, improving patient comfort2.

I NT E LLI GE NT TOU C H S C R E E N I NT E R FAC E Precise dosimetry for greater patient comfort and targeted indications.

DUA L F I B E R LA S E R T E C H NOLOGY Choose between the single or dual fiber laser system. Easily select either the deep penetrating Erbium fiber laser or the more superficial Thulium fiber laser.

H I S TOLOGY C OM PA R I S ON AGA I NS T S U P E R F I C I A L C O 2 – 20 m J

W H AT YO UR PAT IEN T S WA N T – VISIB LE R E S ULT S WI T H M I N I M A L D O W N T I M E C O M PA RED TO A BLAT I VE “ W i th t his technology I c a n o f f e r m y p a t ie n ts c o m f o rt a n d mi ni mal downtime of a n o n -a b la tive t re a t m e n t a n d a c h i e v e amazing results compa ra b le t o s u p e r f ic ia l f ra c tio n a l C O 2 treatments.”

D r. V i c Narukar, San Fra n c is c o, CA

Superficial non-ablative 1927 nm

Superficial ablative CO2 treatment

H&E staining of the 1927 nm Thulium fiber laser showing similar tissue damage as superficial CO2 yet keeping the stratum corneum intact to increase the safety profile of the treatment *All comparisons are made to the original Fraxel System.

Fraxel® DUAL laser SPECIFICATIONS L ASER T YPE

Erbium (Er:fiber) Laser

Thulium (Tm:fiber) Laser

WAV E L E N G T H

1550 nm

1927 nm

PULSE ENERGY

4-70 mJ (per MTZ)

5-20 mJ (per MTZ)

VARIABLE OP TIC AL SPOT SIZE

Optimized for maximum depth of penetration

P U L S E R E P E T I T I O N R AT E

Up to 2,900 MTZs per second provided by ultra high-speed scanner delivery system

system SPECIFICATIONS DELIVERY SYSTEM

Fiber delivery with fiber management system

DIMENSIONS

Laser console: 19” wide x 18” high x 18” deep (48.9 cm x 45.1 cm x 44.5 cm)

WEIGHT

Laser console: 55 lbs (25 kg)

T I P T R E AT M E N T W I D T H

Large tip: 15 mm

U S E R I N T E R FA C E

15” touch-screen display panel

CONTINUOUS MOTION

Handpiece movement rate of 0.3-8.0 cm/sec

SKIN CONTAC T SAFET Y SENSOR

Integrated into handpiece

L ASER TRIGGER

Footswitch, treatment synchronized with hand motion

SYSTEM TEST

Integrated self-test

ELEC TRIC AL

100-240 VAC, universal input 50-60 Hz

O P E R AT I N G C U R R E N T

<6A @ 120V <3A @ 240V

Small Tip: 7 mm

Solta Medical, Inc. 11818 North Creek Parkway North Bothell, WA 98011 info@fraxel.com 425.420.2100 +1.510.786.6946 www.FRAXEL.com

Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies. ©2014 Solta Medical, a division of Valeant Pharmaceuticals North America LLC. All rights reserved.

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