THERACLEAR

K101415 · Theravant Corporation · GEX · Jul 8, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101415
• Device Name: THERACLEAR
• Applicant: Theravant Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris). The TheraClear System is intended for use on all skin types (Fitzpatrick types I-VI).

Device Story

Portable tabletop system delivering intense pulsed light (IPL) to skin treatment sites. Utilizes vacuum technology in delivery handpiece to draw skin into contact with tip; light emission occurs only when tip is sealed against skin, ensuring containment. Used by clinicians in dermatology/surgical settings. Vacuum suction assists in clearing pores/lesions while IPL targets vascular/pigmented structures or acne-related components. Output is controlled light energy; clinical benefit includes lesion reduction, hair removal, and acne management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and identical indications for use compared to the predicate device.

Technological Characteristics

Portable tabletop console with delivery handpiece. Employs intense pulsed light (IPL) energy source. Features vacuum-assisted delivery mechanism for skin contact and light containment. Designed for all Fitzpatrick skin types (I-VI).

Indications for Use

Indicated for treatment of benign vascular and pigmented lesions, permanent hair reduction, and mild to moderate acne (pustular, comedonal, inflammatory/acne vulgaris) in patients of all skin types (Fitzpatrick I-VI).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Aesthera Isolaz System (K083730)

Submission Summary (Full Text)

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K101415

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- 8 2010

## Section 1- 510(k) Summary or 510(k) Statement

#### I. General Information

Submitter:

ﺗﻘ

Theravant Corporation 201 Lindberg Ave Livermore, CA 94551 USA

Contact Person:

Marcy Moore Regulatory Consultant for Theravant Corporation 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-363-0085 fax [e-mail]

May 14, 2010 Summary Preparation Date:

#### Names II.

| Trade Name: | TheraClear System |
|------------------------------|----------------------------------------------------------------------------------------|
| Classification: | Class II |
| | 21 CFR 878.4810 |
| Product Code: | ONF |
| Primary Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |

#### III. Predicate Device(s)

- Aesthera Isolaz System (K083730); .
#### IV. Product Description

The Theravant System is comprised of the following main components:

- Main console .
- Treatment Handpiece(s) .

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The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.

PB 2 of

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#### V. Indications for Use

The Theravant TheraClear System is intended for:

- The treatment of benign vascular and pigmented lesions; ●
- Permanent hair reduction;
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).

The TheraClear System is intended for use on all skin types (Fitzpatrick types I-VI).

#### Rationale for Substantial Equivalence VI.

The TheraClear System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

#### Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics demonstrates that the TheraClear System is substantially equivalent to the predicate devices.

### VIII. Conclusion

The Theravant System was found to be substantially equivalent to the predicate devices.

The Theravant System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings and body represented by a series of curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Theravant Corporation % Ms. Marcy Moore Regulatory Consultant 131 Kelekent Lane Cary, North Carolina 27518

# JUL - 8 2010

Re: K101415

Trade/Device Name: TheraClear System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: May 19, 2010 Received: May 20, 2010

Dear Ms. Moore:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Marcy Moore

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ' that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K10 | 4

Device Name: TheraClear

Indications for Use:

The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including gunsular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all e knowner (Fitzpatrick I-VI).

Prescription Use · > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oli) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number: K014115

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