The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Aklarus combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Aklarus Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm +/- 10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Alarus Infrared (880nm +/-10nm) is intended to emit energy 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 where applied.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the Aklarus Phototherapy System. It outlines the device's details, indications for use, and a comparison to predicate devices, concluding that it is substantially equivalent. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with defined acceptance criteria for novel performance claims. While the Indications for Use mention treating conditions like acne vulgaris, periorbital wrinkles, and pain relief, the document explicitly states: "The proposed Aklarus Phototherapy System when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the predicate devices listed in this section." This suggests that the substantial equivalence was likely based on comparison of technological characteristics and intended use to existing devices, rather than a new standalone clinical study with acceptance criteria.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary.

If such a study had been conducted and included in the submission, significant details on its methodology, results against acceptance criteria, and statistical analysis would typically be found in a separate section of the 510(k) submission, often titled "Clinical Studies" or "Performance Data." This document only provides a summary demonstrating substantial equivalence based on predicates.

Summary

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K083183 p. 1 of

JUL 1 6 2009

SECTION 5: 510(k) Summary

Hill Laboratories, Inc. requests that the attached "summary" for the Aklarus Phototherapy System be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.

510(k) SUMMARY

For Hill Laboratories Aklarus Phototherapy System

Hill Laboratories

3 Bacton Hill Rd

Frazer, PA 19355

1. Submitter's Name and Address

Submitter's Name: Address: City, State, and Zip:

2. Contact Person

Name:	Brady Aller
Title:	Therapeutic Product Manager
Telephone:	(610) 644-2867
Facsimile:	(610) 647-6297
E-mail:	bradyaller@hilllabs.com

Manufacturing Facility Address 3.

Manufacturer:	Hill Laboratories
Address:	3 Bacton Hill Rd
City, State, and ZIP:	Frazer, PA 19355

4. Establishment Registration Number

Establishment Registration 2510425 Number:

5. Reason for Submission

New Device

Date of Summary Preparation 6.

September 6, 2008

7. Device Details

Proprietary or Trade Name: Aklarus Phototherapy System

Aklarus Phototherapy System 510(k)

Section 5-1

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Common Name	Class	ProCode	CFR
Infrared lamp	2	ILY	890.5500
Laser surgical instrument for use ingeneral and plastic surgery and indermatology	2	GEX	878.4810

Classification Name 8.

Lamp, Infrared, Therapeutic Heating Laser Instrument, Surgical, Powered

9. Device Classification Panel

Physical Medicine

10. Indications for Use

The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Primary Predicate Device 11.

510(k) Number	Trade or Proprietary or Model Name	Manufacturer	Class
K060792	Illumimed	Hill Laboratories	2

12. Additional Predicates

1	K050216	1	Omnilux Revive & OmniluxPlus Combo	1 Photo Therapeutics Limited
2	K041103	2	AcneLift	2 Inner Act, LLC

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083183 P.3.f.5

3	K030883	3	Omnilux Blue	3	Photo Therapeutics Limited
4	K043317	4	Omnilux Plus	4	Photo Therapeutics Limited

13. Conclusion

The proposed Aklarus Phototherapy System when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the predicate devices listed in this section.

· ..

、

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body. 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

JUL 1 6 2009

Hill Labortories, Co. % Mr. Brady Aller Therapeutic Product Manager 3 Bacton Hill Road Frazer, Pennsylvania 19355

Re: K083183

Trade/Device Name: Aklarus Phototherapy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ILY Dated: July 10, 2009 Received: July 14, 2009

Dear Mr. Aller:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Brady Aller

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083183 Device Name: Aklarus Phototherapy System Indications for Use:

The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Aklarus combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Aklarus Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm +/-10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Aklarus Infrared (880nm +/-10nm) is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and ioint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Prescription Use × AND/ Over-The-Counter Use (Part 21 CFR 801 Subpart D) OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDE Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ogden formkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083183

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.