(128 days)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing, or descriptions of training/test sets for algorithmic development. The device description focuses on the physical mechanism of action (photothermolysis) and basic electrical/mechanical features.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide phototherapeutic light to the body" for the treatment of various lesions.
No
The device is intended for the treatment of benign pigmented and cutaneous vascular lesions, not for diagnosing them. It uses phototherapeutic light to resolve or lighten lesions.
No
The device description explicitly states it is a "light-based skin care system" and includes hardware components like an AC mains powered and battery powered version, a treatment head, and electrical requirements. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- This device is a light-based system applied directly to the body. Its intended use is for treating skin conditions by applying light energy to the affected areas. It does not involve the analysis of any biological specimens.
The description clearly states it's a "prescription home use device intended to provide phototherapeutic light to the body" for treating various skin lesions. This falls under the category of therapeutic or aesthetic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Product codes
GEX
Device Description
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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
prescription home use device
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)
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. 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. The results of the two tests confirm 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421
Re: K142924
Trade/Device Name: Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family 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 Dated: December 4, 2014 Received: December 5, 2014
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 -ഗ
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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ATTACHMENT 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142924
Device Name
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family
Indications for Use (Describe)
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
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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510(K) Summary
510(K) Summary K142924
| Submitter: | Shaser, Inc.
10 Maguire Road
Lexington, MA 02421 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns
Senior Director of Regulatory Affairs |
| Date Summary Prepared: | October 6, 2014 |
| Device Trade Name: | Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System Family |
| Common Name: | Intense Pulsed Light Therapy System |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal
Effect
79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Sciton Profile Multi-Platform System (K070833)
Shaser Skin Beauty Intense Pulsed Light System Family (K141583) |
| Device Description: | Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System Family
devices are prescription home use, light-based skin care systems. The
family includes an AC mains powered and battery powered version of
the same device.
The Principle of Operation is selective photothermolysis and the
Mechanism of Action is to lighten or resolve lesions using light for
preferentially heating.
Emission activation is by finger switch. Device includes a limited life
treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz,
single phase. |
| Intended Use: | Treatment of benign pigmented lesions and benign cutaneous vascular
lesions. |
| Indications For Use: | The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System
Family is a prescription home use device intended to provide
phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia,
hyperpigmentation, melisma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions, including port
wine stains, hemangiomas, facial, truncal and leg telangiectasias,
rosacea, erythema of rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and venous malformations. |
| Comparison: | The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System
Family has the identical 'Indications For Use', the identical
'Fundamental Science', and the same performance specifications as the
(IPL platform of the) Sciton Profile Multi-Platform System. |
| | Exhibit E (1 of 2)
The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System |
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Family has the identical ‘Fundamental Science’, identical performance specifications, the same design, materials, and funtions as the Shaser Skin Beauty Intense Pulsed Light System Family.
| 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. |
| 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. | |
| The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device. | |
| Conclusion: | The results of the nonclinical and clinical performance data conclusively demonstrates that the proposed device is at least as safe and effective as the Sciton Profile Multi-Platform System and is a safe and effective device for the intended uses. |
| Additional Information: | None |