K Number
K073022
Device Name
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
Manufacturer
Date Cleared
2008-10-01

(341 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 stiffiess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
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.
More Information

Not Found

No
The device description and intended use focus solely on the delivery of LED light at specific wavelengths for therapeutic purposes. There is no mention of any computational analysis, learning algorithms, or data processing that would indicate the presence of AI or ML. The device is described as a simple hand-held device with an ON/OFF switch.

Yes
The device is intended for various therapeutic purposes, including treating vascular and pigmented lesions, acne, muscle and joint pain, and increasing blood circulation, which are all clinical indications for treatment.

No

The device is described as providing light for treatment of various conditions (vascular/pigmented lesions, acne, muscle/joint pain) and does not state that it is used to identify or diagnose any medical condition.

No

The device description explicitly states it is a "hand held device that utilizes Light Emitting Diodes to provide LED light to the body" and contains a "power supply" and "pushbutton switch," indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses described (treatment of skin conditions, pain relief, muscle relaxation, increased blood circulation) all involve applying light to the body for therapeutic purposes. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose diseases or conditions.
  • Device Description: The device description details a hand-held device that delivers light to the skin. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.

The Clareblend Probes are clearly intended for therapeutic use by applying light to the body.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GEX, ILY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body, skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

FDA 510K Summary of Safety and Effectiveness for
OCT 01 2008Clareblend LED Probes
K073022
General Information
Submitter:Clareblend Inc.
3555 Airway Dr.
Suite 307
Reno, Nevada 89511
800-334-7126
775-332-3852 Fax
Contact Person:C/O Jill Creasy
Aesthetica-Tech
675 Pine Street
Elgin, IL 60123
847-429-9631
847-429-9633 Fax
contact@aestheticatech.com
Summary Preparation Date:October 26, 2007
Names
Device Name:Clareblend LED Probe
Model # 7201-415, 7204-631, 7205-830
Classification Name:Laser instrument, surgical, powered device; GEX, ILY
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

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.

1

Comparison of Technological Differences: 6.

Image /page/1/Picture/1 description: The image contains a sequence of characters that appear to be handwritten. The characters include 'K', 'o', '7', '3', '0', '2', and '2'. The characters are written in black ink on a white background. The writing style is casual and somewhat stylized.

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.

2

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

3

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

4

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

Page 1 of