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.

AI/ML Overview

The provided FDA 510(k) Summary for Clareblend LED Probes (K073022) does not contain information about a study with acceptance criteria and reported device performance in the typical sense of a clinical or analytical study.

This document describes a substantial equivalence determination, meaning the device was deemed equivalent to already-marketed predicate devices. For this type of submission, extensive new clinical performance data is often not required if the new device's technological characteristics and intended use are very similar to established devices.

Therefore, many of the requested details about acceptance criteria, study sizes, expert involvement, and ground truth are not applicable (N/A) for this particular document and submission type.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Technological Characteristics:
- Wavelength output matching predicate devices.	- Red: 631 +/- 4nm
- IR: 830 +/- 5nm
- Blue: 415 +/- 5nm
- Device type: Hand-held, LED-based.	- Hand-held device utilizing Light Emitting Diodes.
- Power supply, ON/OFF switch, 100% duty cycle.	- Contains power supply, "alternote action ON/OFF pushbutton switch," applies full power (100% duty cycle).
- Housing material and design.	- 100% machined aluminum, recessed clear lexan window.
Intended Use:
- Be equivalent to the indications for use of predicate devices:	- Clareblend Probe (Red-631): Treatment of superficial, benign vascular and pigmented lesions. (Equivalent to Omnilux Revive in scope, although Omnilux Revive has more general indications).
- Clareblend Probe (Blue-415): Treatment of dermatological conditions, specifically mild to moderate inflammatory acne vulgaris. (Equivalent to Omnilux Blue).
- Clareblend Probe (IR-830): Temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting relaxation of muscle tissue; temporarily increasing local blood circulation. (Equivalent to Omnilux Plus).
Safety and Effectiveness:
- No significant differences in safety or effectiveness compared to predicate devices.	- "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." - "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."

Study Details (Not Applicable/Information Not Provided for this type of Submission)

Sample size used for the test set and the data provenance: N/A. This 510(k) relies on substantial equivalence and does not describe a clinical performance study with a test set of data. The "test" was a comparison to predicate devices, not a new data collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for a test set is not described as no new clinical study data evaluation is referenced.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No test set requiring adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This device is not an AI-assisted diagnostic tool; it's a therapeutic LED light probe. No MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an algorithm or AI device. Its performance is inherent in its physical properties (wavelength, power) and intended biological effect.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. For a substantial equivalence claim, the "ground truth" implicitly refers to the established safety and effectiveness profiles of the identified predicate devices (Omnilux Blue K030883, Omnilux Revive K030426, Omnilux Plus K043317).
The sample size for the training set: N/A. There is no mention of a training set as this is not an AI/ML device.
How the ground truth for the training set was established: N/A. Not applicable as no training set is described.

In summary: The provided document is a 510(k) summary for a device seeking clearance based on substantial equivalence to existing predicate devices. It focuses on demonstrating that the new device's technological characteristics and intended uses are "virtually identical" and pose "no new safety or effectiveness concerns" compared to the predicates. It does not detail new clinical trials or performance studies with specific acceptance criteria beyond the comparison to the predicate devices' established performance and safety profiles.

Summary

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FDA 510K Summary of Safety and Effectiveness for
OCT 01 2008	Clareblend LED ProbesK073022
General Information
Submitter:	Clareblend Inc.3555 Airway Dr.Suite 307Reno, Nevada 89511800-334-7126775-332-3852 Fax
Contact Person:	C/O Jill CreasyAesthetica-Tech675 Pine StreetElgin, IL 60123847-429-9631847-429-9633 Faxcontact@aestheticatech.com
Summary Preparation Date:	October 26, 2007
Names
Device Name:	Clareblend LED ProbeModel # 7201-415, 7204-631, 7205-830
Classification Name:	Laser instrument, surgical, powered device; GEX, ILYFDA 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

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 (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

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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.

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

Regulation Number and Section

§ 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.