(261 days)
Not Found
No
The provided text describes a light therapy device with specific wavelengths for treating dermatological conditions and pain relief. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The focus is on the emitted light spectrum and its therapeutic effects.
Yes
The device is intended to treat specific medical conditions such as acne vulgaris, periorbital wrinkles, muscle and joint pain, and arthritis, which falls under the definition of a therapeutic device.
No
The 'Intended Use / Indications for Use' section describes the device as being used to treat various dermatological conditions (e.g., acne, periorbital wrinkles, muscle pain) by emitting light. There is no mention of the device being used to diagnose or identify any conditions.
No
The intended use and predicate devices clearly indicate this is a light therapy device, which involves hardware emitting specific wavelengths of light for treatment. The lack of a device description doesn't negate the hardware nature implied by the intended use and predicates.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to treating dermatological conditions (acne, wrinkles) and providing topical heating for pain relief and circulation. These are therapeutic applications, not diagnostic ones.
- Device Description: While the device description is "Not Found," the intended use clearly points to a light therapy device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's intended uses fall outside of that definition.
N/A
Intended Use / 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 joint pain, arthritis and muscle spasm; relieving stiffness; 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)
ILY, GEX
Device Description
Proprietary or Trade Name: Aklarus Phototherapy System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
K060792, K050216, K041103, K030883, 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
§ 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.
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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
1
| Common Name | Class | ProCode | CFR |
|---|---|---|---|
| Infrared lamp | 2 | ILY | 890.5500 |
| Laser surgical instrument for use in | |||
| general and plastic surgery and in | |||
| dermatology | 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.
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.
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 & Omnilux
Plus 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
4
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
5
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