The LumaProbe is intended to provide light to the body.
LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular, and pigmented lesions.
LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris.
LumaProbe (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 Description

The LumaProbe is a device that utilizes Light Emitting Diodes to provide LED light to the body. The LumaProbe Red, IR and Blue are a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- nm and Blue is 415 +/- 5nm. The LumaProbe unit contains the power supplies and the control unit; it has the capabilities to power and sequence up to 2 attachable probes depending on the product model, that deliver the light to the skin as they are moved over the skin surface. The STOP button directly on the probes allows the user to immediately remove all power to the probes.

AI/ML Overview

The provided text is a 510(k) Summary for the LumaProbe device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it aims to demonstrate substantial equivalence to predicate devices already on the market.

Therefore, many of the requested categories cannot be filled as they pertain to clinical or performance studies that are not detailed in this submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or report specific performance metrics from a study. It focuses on the LumaProbe's features being "virtually identical" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or study data is described. The submission relies on "comparison of technological differences" and "overall performance characteristics" without detailing a specific study to generate this data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No ground truth establishment is described as there is no specific test set or clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication method is described.

5. 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

Cannot be provided. This device is a light therapy device, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. This device is a physical light therapy device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is established as no specific performance study is detailed.

8. The sample size for the training set

Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Cannot be provided. No ground truth for a training set is relevant or mentioned.

Summary of the K073600 Submission for LumaProbe:

The K073600 submission for the LumaProbe device is a 510(k) Premarket Notification which asserts substantial equivalence to previously cleared predicate devices. It does not present novel performance data from de novo clinical studies with specific acceptance criteria that the device proves to meet. Instead, the core argument is that the LumaProbe is technologically similar to existing devices with established safety and effectiveness.

The relevant section stating this is:

"Comparison of Technological Differences: The intended use and technological characteristics of the LumaProbe system are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the LumaProbe and the equivalent devices have no significant influence on safety or effectiveness of the LumaProbe product."

"Conclusions: Based upon an analysis of the overall performance characteristics for the LumaProbe, Clareblend, Inc. believes that no significant differences exist between this system and the predicate systems quoted, therefore, the LumaProbe Light Therapy device does not impose any new safety or effectiveness concerns."

This means the "acceptance criteria" here are implicitly meeting the performance and safety profiles of the predicate devices based on a technological comparison, rather than direct, quantitative testing against specific numbers.

Summary

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K073600

OCT 01 2008

FDA 510K Summary of Safety and Effectiveness for LumaProbe

1. 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 22, 2007
Names
Device Name:	LumaProbe Model # 7002-01 with hand probes (Models: 7201-415,7204-631, and 7205-830
Classification Name:	Laser instrument, surgical, powered device; GEX, ILYFDA Class II category Although this device is not a laser, the specifications developer feels this is the closest applicable classification name.

3. Predicate Device

LumaProbe is substantially equivalent to the Omnilux Blue (K030883), Omnilux Revive (K030426), Omnilux Plus (K043317)

4. Device Description

5. Indications for Use:

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

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

LumaProbe (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.

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Ko 73000

Comparison of Technological Differences: 6.

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

7. Conclusions

Based upon an analysis of the overall performance characteristics for the LumaProbe, Clareblend, Inc. believes that no significant differences exist between this system and the predicate systems quoted, therefore, the LumaProbe Light Therapy device does 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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 1 2008

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

Re: K073000

Trade/Device Name: LumaProbe Model # 7002-01 with hand probes (Models: 7201-415, 7204-631, and 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 (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.

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 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 Wilkerson

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_073000

Device Name: LumaProbe Model # 7002-01 with hand probes (Models: 7201-415, 7204-631, and 7205-830

Indications for Use:

The LumaProbe is intended to provide light to the body.

LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular, and pigmented A. lesions
LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially в. indicated for the treatment of mild to moderate inflammatory acne vulgaris.
LumaProbe (R-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis C. and muscle spasm, relieving stiffness; 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 CDRH, Office of Device Evaluation (ODE)

Milke

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

K073000

510(k) Number

Page 1 of 1 -

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.