The illumiMed device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation.

Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Use of the accessory "38 red/near infrared LED Wand", 660 ± 10nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature: 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 blood circulation.

Use of the accessory "240 red/near infrared LED Pad", 660 ± 10nm "red" LEDs and of the 940 ±10 mm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation.

Use of the combination of 430 nm "blue" LEDs, 660 nm "red" LEDs and of the 940 nm "near infrared" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Device Description

The submitted device, illumiMed, is a treatment method using specific wavclengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is an affordable, pain-free means to address a variety of dermatological concerns. The IR spectrum is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The control panel displays to the operator what treatment is being performed and provides the user with a choice of using the LED panels on the arm, LED attachments or both for any chosen treatment protocol.

The software component of the device controls an appropriate number of treatment protocols and each protocol can be enabled by a single action push-pad or button on the control panel. The software can be upgraded by the manufacturer.

The illumiMed device is powered by grounded 120 volt electrical power with an operator controlled on/off switch. The device is housed in a unit that is mounted on four wheels allowing it to be moved to any location desired by the operator.

The control panel has push-pads or buttons that control its operation and software functionality. The software functionally can be upgraded by the manufacturer. The device has a panel arm extension that can hold between one (1) and five (5) LED panels and can be cantilevered in any direction for LED treatment of a patient in a prone, seated or standing position. The LED panels can be combinations of LEDs at 7660 nm ("red"), y 940-950 nm (near infrared), and (430 nm ("blue"). The panels can be configured as an individual panel or in combinations up to five panels of LEDs. Accessory LED pads and wands are available for additional treatment modalities with 660 nm, 940 nm and 430 nm LED diodes.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the illumiMed™ device, which is an LED phototherapy system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through extensive clinical trials with pre-defined acceptance criteria and detailed study results typical for novel devices or PMA applications.

Therefore, the document does not contain a detailed study with acceptance criteria and reported device performance in the way one might expect for a new clinical device undergoing rigorous efficacy testing. Instead, it relies on demonstrating that the illumiMed device shares similar technological characteristics and intended uses with existing, legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the information provided, highlighting what is present and what is missing (as it's not typically required for a 510(k) submission of this nature):

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of "acceptance criteria" and "reported device performance" in the context of a clinical efficacy study. The acceptance criteria for a 510(k) submission are primarily centered around substantial equivalence to predicate devices. The "performance" described is in terms of the device's technological characteristics and its intended uses matching those of the predicates.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as presented in the 510(k))
Electrical powered grounded 110 - 120 volts	Yes
LED diodes/infrared light wavelengths	430, 660, 940 nm
Interchangeable panels/modules	Yes
Wand Attachment capability	Yes
Pad Attachment capability	Yes
Energy Output in Joules (430nm)	46 J
Energy Output in Joules (660nm & 940nm)	61 J
Energy Output in mW (430nm)	3.5 mW
Energy Output in mW (660nm & 940nm)	31 mW
Software component present	Yes
Software upgradeable	Yes
Action: temporary relief of minor muscle aches and pain	Yes (for 660nm & 940nm)
Action: improve circulation	Yes (for 660nm & 940nm)
Action: temporary relief from arthritis and muscle spasm	Yes (for 660nm & 940nm)
Action: temporary relaxation of muscle tissue	Yes (for 660nm & 940nm)
Action: photo-aged skin rejuvenation	Yes (for unspecified wavelengths; likely 660/940nm based on predicate comparison)
Action: treat dermatological conditions (mild/moderate acne vulgaris)	Yes (for 430nm, and combination 430nm, 660nm, 940nm)

The "study" that proves the device meets "acceptance criteria" in this context is the comparison to legally marketed predicate devices and the declaration of substantial equivalence. The document explicitly states: "The performance testing and validation studies document that illumiMed is substantially equivalent to the GEX predicates... and the ILY predicate."

The following information is largely not present in this 510(k) submission because it is typically associated with a clinical trial to demonstrate efficacy, which is usually not a requirement for 510(k) substantial equivalence for devices like this light therapy system.

2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical test set from a formal study for performance evaluation, but rather a comparison of technical specifications and intended uses to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a clinical test set is not detailed. The "ground truth" for this submission is the established performance and safety profile of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication 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: Not applicable. This device is an LED phototherapy system, not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a treatment device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) submission is the regulatory established safety and efficacy of the predicate devices based on their prior marketing clearance. The submission relies on the assertion that illumiMed performs "as well as the predicate devices" (Section I).

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable. As above, no training set or its ground truth establishment is described.

Summary

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DEC - 1 2006

PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92

Device Name - as required by 807.92(a)(2):

Trade Name:	illumiMed™
Common/Classification Name:	LED Phototherapy/Laser Instrument, Surgical, Poweredand Infrared lamp
Classification Regulation(s):	878.4810 and 890.5500
Device Class:	Class II
Product Codes (Procode):	GEX and ILY
Premarket Notification submitter:
Company Name:	PhotoActif, LLC
Company Address:	1959 South Power Road, Suite 103-313
	Mesa, Arizona 85206
Company Phone:	(480) 827-1212
Company FAX:	(480) 827-1213
Contact:	Jeremy Shellman, President and CEO
Preparation Date:	March 8, 2006 (amended October 19, 2006)

LEGALLY MARKETED PREDICATE DEVICE – as required by A. 807.92(a)(3). For details, see Exhibit 13.

The identified legally marketed GEX predicate devices identified by the submitter are:

Omnilux Revive and Omnilux Plus Combination, K050216, from . Photo Therapeutics Limited, Cheshire, United Kingdom
Omnilux Blue, K030883, from Photo Therapeutics Limited, Cheshire, . United Kingdom
RevLight®, Skincare System, K042630, from Skincare Technology Inc., . Chicago, IL
AcneLift, K041103, from Inner Act LLC, Reno, Nevada. .

One legally marketed ILY predicate device is:

Omnilux Plus, K043317, from Photo Therapeutics Limited, Cheshire, . United Kingdom.

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B. DEVICE DESCRIPTION - as required by 807.92(a)(4)

C. DEVICE CLAIMS - as required by 807.92(a)(4)

The illumiMed device is intended to emit energy to treat dermatological conditions including mild to moderate acne vulgaris. The illumiMed is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

PRODUCT AND TECHNICAL SPECIFICATIONS - as required by D. 807.92(a)(4)

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E. INTENDED USE - as required by 807.92(a)(5)

F. INDICATIONS FOR USE - See Exhibit 3.

Use of 430 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Use of the 660 nm "red" LEDs and of the 940 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

Use of the accessory 38 blue LED Wand is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

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Use of the accessory 38 red/near infrared LED Wand is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

Use of the accessory 240 red/near infrared LED Pad is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

G. LEVEL OF CONCERN - as requested by recent FDA guidance

The FDA guidance document "Guidance For The Content of Premarket Submissions For Software Contained In Medical Devices," May 11, 2005, provides tables that the submitter used to identify the Level of Concern for the submitted device. See Exhibit 4 - Level of Concern.

The submitter, following approved procedures, assessed the device's software component for Level of Concern and completed the submitter's form F 0014F, Level of Concern Assessment and Certification.

Since the submitted device's software is neither a Major Level of Concern or a Moderate Level of Concern, PhotoActif's completed form F 0014F documents and the submitter claims the determination that the illumiMed device's software component can only be a MINOR Level of Concern.

H. TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by 807.92(a)(6)

The technological characteristics available in illumiMed device include:

The submitted device provides a treatment method, using specific wavelengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes), to treat a variety of skin and body conditions.

The device operates on grounded 110 volt power and is intended to be moved on its wheels to any appropriate location for use. The device has storage space for optional attachments and topicals.

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A control panel provides for manual and software controlled treatment protocols, specifically with the:

1. Use of the four hundred ninety two (492) LED's panel-mounted on the panel arm with:
  Four hundred nincty two (492) 430 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
1. Use of the five hundred seventy six (576) LED's pancl-mounted on the panel arm with:
  Two hundred eighty eight (288) 660 nm "red" LEDs and two hundred eighty eight (288) 940 nm "near infrared" LEDs is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.
1. The use of the accessory thirty eight (38) LED Wand with:
  Twenty (20) 660 nm "red" LEDs and Eighteen (18) 940 nm "near infrared" LEDs is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.
1. The use of the accessory thirty eight (38) LED Wand with:
  Thirty eight (38) 430 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
1. The use of the accessory two hundred forty (240) LED Pad with:
  One hundred twenty (120) 660 nm "red" LEDs and one hundred twenty (120) 940 nm "near infrared" LEDs is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

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1. Use of the combination of 430 nm "blue" LEDs, 660 nm "red" LEDs and of the 940 nm "near infrared" LEDs:
  Is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris

Currently, the device has software protocols that are activated by pushbutton controls on the Control Panel for:

Acne
The device's Control Panel also provides for manual operation and has three (3) buttons, "A," "B," and "C," for future treatments that would be provided by the submitter as software updates to the current software version.

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.60792

ABLE OF SIMILARITIES AND DIFFERENCES BETWEEN

	GEX/ILY	GEX	GEX	ILY
Characteristic	illumiMed	Omnilux Revive &Omnilux PlusCombo K050216	RevLightK042630	AcneLiftK041103	Omnilux BlueK030883	OmniluxPlusK043317
Electrical powered grounded 110 - 120 volts	Yes	Yes	Yes	Yes	Yes	Yes
LED diodes/infrared light	430, 660, 940 nm	Revive: 633 nmPlus: 830 nm	"420 - 940 nm"	405 nm	417 nm	830 nm
Interchangeable panels/modules	Yes	Yes	Yes	No	No	No
Wand Attachment	Yes	No	No	No	No	No
Pad Attachment	Yes	No	No	No	No	No
Energy Output in Joules	430nm = 46660nm &940nm = 61	Revive = 126Plus = 66	*48	#50	*48	*66
Energy Output in mw	430nm = 3.5660nm &940nm = 31	Revive = 105Plus = 55	*4200	#45	*40	*55
Software component	Yes	Yes	No	No	Yes	Yes
Software upgradeable	Yes	Unknown	n/a	No	Unknown	Unknown
Action to provide temporary relief ofminor muscle aches and pain	Yes	Yes	Yes	No	No	Yes
Action to improve circulation	Yes	Yes	Yes	No	No	Yes
Action to provide temporary relieffrom arthritis and muscle spasm	Yes	Yes	Yes	No	No	No
Action to provide temporaryrelaxation of muscle tissue	Yes	Yes	Yes	No	No	Yes
Action to provide for photo-agedskin rejuvenation	Yes	Yes	Yes	No	No	Yes
Action to treat dermatologicalconditions and specifically formoderate inflammatory acne vulgaris	Yes	No	Yes	Yes	Yes	No

8 of 9

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SUBSTANTIAL EQUIVALENCE SUMMARY I.

The submitted device, illumiMed, has the same indications for use as the predicate devices.

illumiMed has the same or very similar technological characteristics as the identified predicate devices. However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation and performance testing to further document substantial equivalence. The results of this testing substantiates that illumiMed performs as well as the predicate devices.

.J. CONCLUSIONS

The performance testing and validation studies document that illumiMed is substantially equivalent to the GEX predicates Omnilux Revive and Omnilux Plus Combination [K050216], Omnilux Blue [K030883], RevLight, Skincare System [K042630], and AcneLift [K041103]; and the ILY predicate Olmuilro Revive [K030426].

The submitter's claim the submitted device is safe and effective for its intended use as both a prescription and non-prescription device.

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Public Health Service

Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PhotoActif, LLC % Mr. Jeremy Shellman President and CEO 1959 South Power Road, Suite 103-313 Mesa, Arizona 85206

Re: K060792 Trade/Device Name: illumiMed™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY, GEX Dated: October 18, 2006 Received: October 20, 2006

Dear Mr. Shellman:

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.

DEC = I 2006

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 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.

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Page 2 - Mr. Jeremy Shellman

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Sincerel Myours.

Kol P
Mark N. Malkerson

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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K060792

Device Name: illumiMedTM

Indications For Use:

Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

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510 (k) Number: K060792

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use_ (Per 21 CFR 801,109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

OFF

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

510(k) Number L060792

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.