CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830

K073022 · Clareblend, Inc. · GEX · Oct 1, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073022
• Device Name: CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
• Applicant: Clareblend, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Clareblend Probes are intended to provide light to the body. Clareblend Probe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris. Clareblend Probe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Story

Clareblend LED Probes are handheld devices delivering light to skin via LEDs. Device contains power supply and probe with pushbutton ON/OFF switch. Operates at 100% duty cycle. Housing is machined aluminum with recessed clear lexan window. Output is pre-tuned to narrow spectral bandwidth: Red (631nm), IR (830nm), or Blue (415nm). Used by clinicians to treat dermatological conditions, vascular/pigmented lesions, or provide pain relief. Light application over skin surface; provider observes treatment area to guide application. Benefits include lesion treatment, acne management, and temporary pain/stiffness relief.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Handheld LED device; machined aluminum housing with clear lexan window. Wavelengths: Red 631+/-4nm, IR 830+/-5nm, Blue 415+/-5nm. 100% duty cycle. Manual pushbutton operation. No software or complex electronics described.

Indications for Use

Indicated for patients requiring treatment of superficial, benign vascular and pigmented lesions (Red-631); dermatological conditions and mild to moderate inflammatory acne vulgaris (Blue-415); or temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and promotion of muscle relaxation and local blood circulation (IR-830).

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

• Omnilux Blue (K030883)
• Omnilux Revive (K030426)
• Omnilux Plus (K043317)

Submission Summary (Full Text)

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| FDA 510K Summary of Safety and Effectiveness for | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| OCT 01 2008 | Clareblend LED Probes<br>K073022 |
| General Information | |
| Submitter: | Clareblend Inc.<br>3555 Airway Dr.<br>Suite 307<br>Reno, Nevada 89511<br>800-334-7126<br>775-332-3852 Fax |
| Contact Person: | C/O Jill Creasy<br>Aesthetica-Tech<br>675 Pine Street<br>Elgin, IL 60123<br>847-429-9631<br>847-429-9633 Fax<br>[e-mail] |
| Summary Preparation Date: | October 26, 2007 |
| Names | |
| Device Name: | Clareblend LED Probe<br>Model # 7201-415, 7204-631, 7205-830 |
| Classification Name: | Laser instrument, surgical, powered device; GEX, ILY<br>FDA Class II category |
| | Although this device is not a laser, the specifications devel |

Although this device is not a laser, the specifications developer feels this is the closest applicable classification name.

#### 3. Predicate Device

1.

2.

Clareblend LED Probes Models 7201-415, 7204-631, 7205-830 are substantially equivalent to Omnilux Blue (K030883), Omnilux Revive (K030426), Omnilux Plus (K043317)

#### 4. Device Description

The Clareblend Probes are hand held devices that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supply. The probe will be simply activated by an alternote action ON/OFF pushbutton switch which is located on the top of the probe. The probe when activated anplies full power (100% duty cycle). The OFF button is provided for the user to immediately remove all power to the probes. The probe housing is 100% machined aluminum and has a recessed clear lexanowindow. The device delivers the light to the skin as it moves over the skin. The output is pre-tuned to one wavele. gth a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- 5mm and Blue is 415 +/- 5nm.

#### 5. Indications for Use:

Clareblend Probe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions

Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris,

Clareblend Probe (R-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

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#### Comparison of Technological Differences: 6.

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The intended use and technological characteristics of the Clareblend Probes are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the Clareblend Probes and the equivalent devices have no significant influence on safety or effectiveness of the Clareblend Probes product.

#### 7. Conclusions

Based upon an analysis of the overall performance characteristics for the Clareblend Probes, Clareblend, Inc. believes that no significant differences exist between this system and the predicate systems quoted, therefore, the Clareblend Probes do not impose any new safety or effectiveness concerns.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all capital letters and is written in a simple, sans-serif font. The logo is black and white.

OCT 01 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clareblend, Inc. % Aesthetica-Tech Ms. Jill Creasy Medical Device Consultant 675 Pine Street Elgin, Illinois 60123

Re: K073022

Trade/Device Name: Clareblend LED Probes Model # 7201-415, 7204-631, 7205-830 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ILY Dated: September 15, 2008 Received: September 18, 2008

Dear Ms. Creasy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Ms. Jill Creasy

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K_073022

Device Name: Clareblend LED Probes Model # 7201-415, 7204-631, 7205-830

### Indications for Use:

The Clareblend Probes are intended to provide light to the body.

Clareblend Probe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions

Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris.

Clareblend Probe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffiess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Prescription Use X AND/OR (21 CFR Part 801 Subpart D)

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

> Concurrence of ODRH valuation (ODE)

Mark N. Milkenon

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

K07 3022

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