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TheraClear™ Acne Therapy System

TheraClear™ Acne Therapy System

Product Features Indications Applications Specifications
Brochure Billing Code FAQs Testimonials
Patient Flip Chart Safety System Components Clinical Training Guide
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Without oral medication, topical treatments or harsh chemicals, The TheraClear™ Acne System removes the cause of all types of acne during a few comfortable office visits.

The TheraClear™ Acne System Highlights:

  • Combines light and vacuum for fast and visible reduction in acne and associated redness
  • Mechanically evacuates sebum and acne causing bacteria for immediate outcomes
  • Effective on non-responders to other acne treatments
  • Requires no pre-treatment gels or anesthetics
  • 4-6 ten minute treatments that are painless.
  • 10 minutes to a 90% Success Rate!

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Indications:

The TheraClear™ Acne System is the only continuously cooled device FDA cleared for the treatment of multiple acne indications on all skin types. Specific Indications include:

  • Mild to inflammatory acne (acne vulgaris)
  • Pustular acne
  • Comedonal acne

Click here for Average Reimbursement Information

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Application:

TheraClear's two-part process utilizes a vacuum and broadband light to clean, treat and remove the blocks to clear skin. Treatments are quick to perform and highly effective.

Vacuum: Deep cleanses the pore by extracting the blocked sebaceous material.

Broadband Light: Light targets porphryns, destroying the P. acne bacteria, reduces sebum production, and dramatically reduces the erythema (redness), and pigmentary changes associated with acne.

The TheraClear™ Acne System Vacuum and Light Treatment

Most acne patients require 4 or 5 treatments every week to two weeks. Usually after one treatment, there is very little improvement. After the second treatment, the patient should notice a modest improvement. The third treatment, however seems to produce the most significant improvement and after the fourth and fifth treatment, most if not all the acne lesions should be gone.

During this series of treatments, the patient may remain on any traditional acne therapies they feel comfortable using. They also should maintain a good skin care regimen which as the doctor, you can influence with recommended protocols. Following the final treatment, the patient may also remain on any therapies they feel comfortable with and also must maintain a good skin care regimen.

Most patients require a single touch up treatment every three to four months.

The TheraClear™ Acne Surgery Insert Treatment

Treatment with The TheraClear™ Acne Surgery Insert(364-0460) is generally performed on the session. Not every patient is treated with this insert. It is used to target the largest acne lesions, particularly ones that are firmly embedded under the skin. The image below shows a typical lesion treated with the acne surgery insert.

The use of The TheraClear™ Acne Surgery Insert is very helpful in treating young to middle age adults with a few lesions that distract from an otherwise ideal complexion. Results generally show up within a few days to a week after a session.

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Specifications:

Features
Weight 37 lbs. (17kG)
Dimensions 13" x 16.5" x 15" (330 x 420 x 380 mm)
Operating Radius of Umbilical: 70" (1.8 M)
Regulatory S3-5 Sector Annular (3-5 MHz) –
Requirements B/M Mode + PW Doppler
Electromagnetic Interference IEC – 60601-1-1 Compliant
IEC – 60601-1-2 Compliant
Wavelength 500 nm – 1200 nm
Spot Sizes 12.7 mm x 25.4 mm and 10mm X 12mm
Pulsewidth Up to 25ms
Short Pulse: 3 ms
Long Pulse: 25 ms
Fluence/Energy Up to 25 J/cm2
Single Pulse: up to 8 J/cm2
Double Pulse: up to 16 J/cm2
Triple Pulse: up to 24 J/cm2
Light Delivery Three (3) Xenon flash lamps within Handpiece. Limited to approximately 100,000 pulses.
Repetition Rate Up to .5 Hz
Single Pulse: One pulse every 2 seconds
Double Pulse: One pulse every 2.5 seconds
Triple Pulse: One pulse every 3 seconds.
Actuator Trigger on Handpiece
Voltage, Frequency and Current 100–240VAC, 50/60Hz, 10A
Max Power Input Temperature: 10-38° C (50-100° F)
Humidity: 10-70% non-condensing
Pressure: 83-110 kPa
Transport/Storage Temperature: 0-50° C (32-124° F)
System Cooling 92% Water, 8% Methanol cooling system
Warrantee One Year Warranty on the TheraClear Acne System including 100,000 pulse warranty on hand piece. Additional warrantee available for purchase separately

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Safety:

The TheraClear™ System was designed to require minimal maintenance.

Service contracts are recommended for regular cost effective maintenance. To learn more about service contracts and user maintenance, please contact your Henry Schein Sales Consultant for information.

High voltages are present inside the TheraClear™ System. It is possible for any intense pulsed light emitting device to cause injury if used improperly.

The TheraClear™ System is not designed to be user-serviceable. It should only be opened, serviced or repaired by Theravant trained and authorized personnel.

All warranties are invalid if the device is opened by anyone other than a Theravant trained and authorized technician.

Please advise your Henry Schein Sales consultant if your unit is in in need of service.

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FAQs:

1) How does the TheraClear System work?

2) How many treatments are needed and how long between treatments?

3) How long do results last?

4) Can my nurse, aesthetician or med tech operate TheraClear?

5) Can patients be on other acne medication while using TheraClear?

6) Where does all the debris pulled out of the skin go?

7) Why is this better than other acne treatment devices?

 

1) How does the TheraClear System work?

Answer: The combination of light and vacuum removes the sebum from the pilosebaceous acne and thereby removes the cause of the acne lesion.

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2) How many treatments are needed and how long between treatments?

Answer: Number of treatments:

  • 4 – 5 treatments
  • More treatments for more severe acne cases

Treatment interval: Weekly to bi-weekly

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3) How long do results last?

Answer: Patients typically stay clear for three months post-treatment. Those on maintenance regimens have stayed clear for a year or more.

Patients who have completed a course of treatments typically note:

  • Fewer breakouts
  • Reduction in the severity of breakouts
  • Reduction in the duration of breakouts
  • Reduction in the oiliness of skin

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4) Can my nurse, aesthetician or med tech operate TheraClear?

Answer: Your state determines who can operate TheraClear. In most states, aestheticians perform the treatments.

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5) Can patients be on other acne medication while using TheraClear?

Answer: Yes

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6) Where does all the debris pulled out of the skin go?

Answer: Most of it ends up on the face and is wiped off with a cloth. A small amount ends up in the insert and can be cleaned off with a cotton-tipped applicator.

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7) Why is this better than other acne treatment devices?

Answer: Comparative energy-based devices do not have a suction component. Without the suction, the sebum remains inside the pilosebaceous gland making the treatment far less effective. Also, TheraClear is the only unit that has cooling function built into the device. Consult the accompanying chart for a comparison of indicated acne therapies.

TheraClear™ vs. Other Common Treatments for Acne
Treatment Duration Before You See Results Potential Side Effects
TheraClear™ Immediate calming of lesions within 24-48 hrs., improvement of redness and brown discoloration associated with lesions
OTC Medication 6-10 Weeks Ineffective; skin irritation; allergic reactions; excessive dryness of skin
Oral Antibiotics 6-8 Weeks Can promote bacterial resistance, dizziness, nausea, vomiting, skin pigmentation changes; Sun sensitivity; Yeast infections and reduction in potency of birth control pills in women
Isotretinoin (Acutane®) 3-6 Months Potential birth defects; mood changes; Excessive dry and chapped lips; Irreversible visual changes; Joint pain, bowel disease
Traditional Lasers 2-4 Weeks Painful, Dyspigmentation

Related Articles: FDA Warns of Serious Risks with OTC Acne Treatments - Click here to view article »

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Billing Code:

CPT Code Description Average Reimbursement* or Cash Physician Fee Annual Revenue
Based on 5 Procedures Per Week Based on 10 Procedures Per Week
10040 Mechanical extraction of acne $125-$150 $32.5K-$39K $65K-$72K

*Source CMS Data. Consult your local fee schedule for actual reimbursements, facility fees, and modifiers.

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System Components - The Complete TheraClear Acne System (364-0457) Contains:

  • TheraClear™ Base Unit (with attached Handpiece)
  • TheraClear™ Acne Therapy Machine
  • 20 TheraClear™ Regular Inserts(364-0458)
  • 20 TheraClear™ Small Inserts(364-0459)
  • 10 TheraClear™ Acne Surgery Inserts(364-0460)
  • Hospital-Grade Power Cord
  • Clinical Training Guide

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Order Number Description Qty Included
364-0457 TheraClear™ Acne System 1
364-0458 TheraClear™ Regular Insert 20
364-0459 TheraClear™ Small Insert 20
364-0460 TheraClear™ Acne Surgery Insert 10

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