(227 days)
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No
The 510(k) summary describes a topical solution for dermatological conditions and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is indicated to manage and relieve symptoms like burning, itching, erythema, and scaling associated with various dermatoses, functioning as a non-sterile, oily solution for topical application. This aligns with the definition of a therapeutic device as it directly treats or alleviates medical conditions or their symptoms.
No
The device is described as an oily solution for topical application to manage and relieve symptoms of dermatoses, not to diagnose a condition.
No
The device description explicitly states that LOYON is a "non-sterile, oily solution" supplied in "amber glass bottles with a pump sprayer," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that LOYON is indicated for the management and relief of symptoms associated with various dermatoses. This is a therapeutic or symptomatic treatment, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: LOYON is described as an "oily solution, exclusively indicated for topical application." This further reinforces its use as a treatment applied to the skin, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, analysis of biological specimens, or the generation of diagnostic results.
- Performance Studies: The performance studies described (Biocompatibility Testing and Bench Testing) focus on the safety and physical characteristics of the topical solution, not on its ability to diagnose a condition.
- Predicate Devices: The predicate devices listed are also topical treatments for skin conditions, not IVDs.
In summary, LOYON is a topical medical device intended for the symptomatic relief of dermatological conditions, not for the diagnosis of those conditions.
N/A
Intended Use / Indications for Use
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.
Product codes
FRO
Device Description
LOYON® is a non-sterile, oily solution, exclusively indicated for topical application. LOYON® is used to manage and relieve burning and itching and scaling experienced with various types of dermatoses. It will be supplied in 15mL or 50mL amber glass bottles with a pump sprayer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a health care professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The biocompatibility evaluation for LOYON® was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. LOYON® was evaluated for cytotoxic, irritating, sensitizing, and leachable effects.
Bench Testing: The following tests were performed to support the performance of LOYON®: visual inspection, odor (sensory), viscosity, functional checks, leakage test, volume check, and microbiological bioburden. LOYON® meets specification and performance characteristics and is substantially equivalent to the predicate devices.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Oculus Innovative Sciences Mr. Brian Martin Director Of Regulatory Affairs And Quality Control 1129 N. McDowell Boulevard Petaluma. California 94954
Re: K162217
Trade/Device Name: Loyon Regulatory Class: Unclassified Product Code: FRO Dated: February 14, 2017 Received: February 15, 2017
Dear Mr. Martin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162217
Device Name Loyon
Indications for Use (Describe)
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized golden swirl above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller, lighter font.
1 510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
I. SUBMITTER
Oculus Innovative Sciences, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551 Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: March 17, 2017
Device Manufacturer: G. Pohl Boskamp GmbH & Co. KG Kieler Straße 11 D-25551 Hohenlockstedt Germany
II. DEVICE
Name of Device: LOYON® Common or Usual Name: Antipruritic Solution Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICES
Alevicyn SG Antipruritic Gel manufactured by Oculus Innovative Sciences (K152945) Tropazone manufactured by Akorn Phamaceuticals (K090337)
IV. DEVICE DESCRIPTION
LOYON® is a non-sterile, oily solution, exclusively indicated for topical application. LOYON® is used to manage and relieve burning and itching and scaling experienced with various types of dermatoses. It will be supplied in 15mL or 50mL amber glass bottles with a pump sprayer.
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Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo consists of a stylized gold-colored graphic above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller, serif font. The graphic above the word "OCULUS" appears to be three concentric ellipses.
V. INDICATIONS FOR USE
Rx Indication: Under the supervision of a health care professional, LOYON is indicated to manage and relieve the burning, itching, erythema, and scaling experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, and seborrhea and seborrheic dermatitis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICES
| Submitter/
Holder | Proposed Device:
LOYON® | Predicate Device:
K152945 Alevicyn SG Gel, | Predictae Deive: Tropazone
K090337, Akorn Phamaceuticals. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Oculus Innovative Sciences | Oculus Innovative Sciences | |
| Indications
for
Use | Rx Indication: LOYON® is
indicated to manage and relieve
the burning, itching, erythema,
and scaling experienced with
various types of dermatoses,
including atopic dermatitis,
radiation dermatitis, and seborrhea
and seborrheic dermatitis. | Rx Indication: Alevicyn SG Gel is
indicated to manage and relieve the
burning, itching, erythema, scaling, and
pain experienced with various types of
dermatoses, including atopic dermatitis,
radiation dermatitis, and seborrhea and
seborrheic dermatitis. The Alevicyn SG
Gel may also be used to relieve the pain
of first and second degree burns. Alevicyn
SG Gel helps to relieve dry waxy skin by
maintaining a moist wound & skin
environment, which is beneficial to the
healing process. | Tropazone Lotion is used to
manage and relieve the burning and
itching experienced with various
type of dermatoses, including
radiation dermatitis, atopic
dermatitis, and allergic contact
dermatitis. It helps relieve dry
waxy skin by maintaining a moist
wound and skin environment,
which is beneficial to the healing
process. |
| Mechanism
of Action | Emollient | Same | Same |
| Delivery
System | Bottle with spray | Bottle with spray | Tube/ Lotion |
| Sterility | Non-sterile
Water Activity USP
Conforming to USP | Non-sterile
Preserved/Conforming to USP | Non Sterile - Preserved |
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for LOYON® was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. LOYON® was evaluated for cytotoxic, irritating, sensitizing, and leachable effects.
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Image /page/5/Picture/0 description: The image shows the text 'K162217' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The number is likely an identifier or code of some kind.
Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo consists of the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Sciences" in a smaller font below it. Above the word "OCULUS" is a graphic of several overlapping circles.
Bench Testing
The following tests were performed to support the performance of LOYON®: visual inspection, odor (sensory), viscosity, functional checks, leakage test, volume check, and microbiological bioburden. LOYON® meets specification and performance characteristics and is substantially equivalent to the predicate devices.
CONCLUSION VIII.
LOYON® is substantially equivalent in intended use, with different technological characteristics, that does not raise different safety and effectiveness questions compared to Alevicyn SG Antipruritic Gel manufactured by Oculus Innovative Sciences, Inc. (K152945) and Tropazone (K090337). Therefore, LOYON® is substantially equivalent to the predicate devices.