(111 days)
No
The summary describes a light-based device with a simple activation mechanism and focuses on phototherapeutic principles, with no mention of AI, ML, or complex data processing.
Yes
The device is intended for the "treatment of individual acne pimples" to "reduce inflammation due to acne", which are therapeutic actions.
No
The device is intended for the treatment of acne, specifically to provide phototherapeutic light and reduce inflammation, not to diagnose a medical condition.
No
The device description explicitly states it is a "Light-Based Acne Clearing Device" and includes hardware components such as a "limited life treatment head and battery charger/AC cord." It also mentions electrical requirements and a principle of operation that is both photochemical and photothermal, indicating a physical device that emits light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is an "over-the-counter home use device intended to provide phototherapeutic light to the body" for the treatment of acne. It applies light directly to the skin, not to a sample taken from the body.
- Mechanism of Action: The mechanism of action involves stimulating oxygen production and reducing inflammation in situ (on the skin), not analyzing a biological sample.
Therefore, the Shaser Skin Beauty Intense Pulsed Light System Family for Acne falls under the category of a therapeutic device that interacts directly with the body, not an in vitro diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Product codes
ONF
Device Description
Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use / Over-The-Counter Use
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
Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated home-use environment. 84 study subjects were tested for label comprehension and for usability. The test populations included low literacy subjects. The results of the two tests confirms sufficient label comprehension and safe and appropriate use of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing for performance verification and electrical safety testing.
Clinical Performance Data: Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated home-use environment. 84 study subjects were tested for label comprehension and for usability. The test populations included low literacy subjects. The results of the two tests confirms sufficient label comprehension and safe and appropriate use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping each other, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421
Re: K150282
Trade/Device Name: Shaser Skin Beauty Intense Pulsed Light System Family for Acne 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: ONF Dated: April 30, 2015 Received: May 4, 2015
Dear Mr. Burns:
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 (reporting of medical
1
device-related 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.
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/Resourcesfor You/Industry/default.htm. 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/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 yours,
Jennifer R. Stevenson -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) K150282
Device Name
Shaser Skin Beauty Intense Pulsed Light System Family for Acne
Indications for Use (Describe)
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) Summary
| Submitter: | Shaser, Inc.
10 Maguire Road
Lexington, MA 02421 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns
Senior Director of Regulatory Affairs |
| Date Summary Prepared: | January 30, 2015 |
| Device Trade Name: | Shaser Skin Beauty Intense Pulsed Light System Family For Acne |
| Common Name: | Light Based Acne Clearing Device |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal
Effect
79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Shaser Skin Beauty Intense Pulsed Light System Family (K141583)
CLRS Technology Corp. CLARO (K090744) |
| Device Description: | Shaser Skin Beauty Intense Pulsed Light System Family For Acne is
an Over-The-Counter, Light-Based Acne Clearing Device. Emission
activation is by finger switch. Device includes a limited life treatment
head and battery charger/AC cord. Electrical requirement is 115 VAC,
15A, 50-60 Hz, single phase.
The Principle of Operation is both photochemical and photothermal.
The Mechanism of Action is to stimulate oxygen production which
attacks p.acne and to reduce inflammation due to acne. |
| Intended Use: | Treatment of Acne. |
| Indications For Use: | The Shaser Skin Beauty Intense Pulsed Light System Family for Acne
is an over-the-counter home use device intended to provide
phototherapeutic light to the body. It is also indicated for the
treatment of individual acne pimples in persons with mild to moderate
inflammatory acne. |
| Comparison: | The Shaser Skin Beauty Intense Pulsed Light System Family For Acne
has the same principle of operation and light source, and very similar
wavelength range and pulse energy as the predicate devices. The
proposed device has the same Intended Use as the CLARO predicate
device. |
| Nonclinical Performance Data: | Bench testing for performance verification and electrical safety testing. |
| Clinical Performance Data: | Label comprehension and usability test of consumers' ability to
understand the instructions for use and to evaluate their ability to use
the device safely in a simulated home-use environment.
• 84 study subjects were tested for label comprehension and for
usability. The test populations included low literacy subjects.
The results of the two tests confirms sufficient label comprehension
and safe and appropriate use of the device. |
| Conclusion: | The Shaser Skin Beauty Intense Pulsed Light System Family For Acne
is a safe and effective device for the intended use. |
| Additional Information: | None |
Exhibit E (1 of 2)
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5
TABLE OF COMPARATIVE FEATURES
| | Proposed 510(k) Device | Predicate Device 510(k)
K090744 | Predicate Device
510(k) K141583 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shaser, Inc. | CLRS Technology Corp. | Shaser, Inc. |
| Trade Name | Shaser Skin Beauty Intense Pulsed
Light System Family for Acne | CLARO | Shaser Skin Beauty Intense Pulsed Light System
Family |
| Intended Use | Acne Clearing Device | Acne Clearing Device | Removal of Unwanted Hair |
| Indications | The Shaser Skin Beauty Intense
Pulsed Light System Family for
Acne is an over-the-counter home
use device intended to provide
phototherapeutic light to the body,
specifically indicated for the
treatment of individual acne
pimples in persons with mild to
moderate inflammatory acne. | The CLARO is indicated for
the treatment of individual
acne pimples in persons with
mild to moderate
inflammatory acne. | The Shaser Skin Beauty Intense Pulsed Light System
Family is an over-the-counter home use device
intended to provide phototherapeutic light to the
body. It is also intended for removal of unwanted hair
by using a selective photothermal treatment. It is also
indicated for the removal of unwanted body and/or
facial hair in adults with Fitzpatrick skin types I – IV.
The Shaser Skin Beauty Intense Pulsed Light System
Family is also intended for permanent reduction in
unwanted hair. Permanent hair reduction is defined as
the long-term stable reduction in the number of hairs
regrowing when measured at 6, 9, and 12 months
after the completion of a treatment regimen. |
| 'Use'
Classification | OTC | OTC | OTC |
| Device
Classification | Class II | Class II | Class II |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| | Proposed 510(k) Device | Predicate Device
510(k) K090744 | Predicate Device
510(k) K141583 |
| Wavelength (nm) | 400 - 1100nm | 400 - 1100nm | 400 - 1200nm |
| Max. Fluence
(J/cm²) | 6.0 | 6.0 | 10 |
| Spot Size (cm²) | 2.0 | 1.0 | 2.0 |
| Pulse Width (s) | 6 | 6 |