(148 days)
Not Found
No
The description focuses on LED and micro vibration technology with fixed parameters, and there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as "intended for medical purposes to relieve minor aches and pains" and treats "mild to moderate acne" and "preorbital wrinkles." These are therapeutic claims.
No
The device description and intended use state that the LYFT device is for treatment (e.g., acne, wrinkles, aches, pains) and does not mention any diagnostic functions.
No
The device description clearly states it is a "hand-held, rechargeable Li-Polymer battery powered device" with LED and micro vibration functional modes, indicating it is a physical hardware device, not software only.
Based on the provided information, the LYFT device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses of the LYFT device are for treating acne, periorbital wrinkles, and relieving minor aches and pains. These are all therapeutic or physical treatment applications, not diagnostic tests performed on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The device description details its physical characteristics, power source, and functional modes (LED and micro vibration). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-Specific Information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of specific analytes (e.g., biomarkers, pathogens).
- Diagnostic claims or interpretations based on sample analysis.
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating diagnostic accuracy.
The LYFT device is a therapeutic medical device that applies energy (light and vibration) directly to the body for treatment purposes.
N/A
Intended Use / Indications for Use
The LYFT device is intended to be used:
LED functional mode
- To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
Micro Vibration functional mode - As an electrically powered device intended for medical purposes to relieve minor aches and pains.
Product codes
OLP
Device Description
The LYFT is a hand-held, rechargeable Li-Polymer battery powered device used for the treatment of mild to moderate acne, preorbital wrinkles, and the relief of minor aches and pains. The LYFT devices combines two (2) functional modes of operation, LED and micro vibration. The LED functional mode provides narrow bandwidth spectral output in the blue (430 ± 5 nm) and red (625 ± 5 nm) ranges. The micro vibration functional mode operates at a fixed frequency of 3 MHz ± 5%. The LYFT device uses a supplied power adaptor and is rechargeable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face (for acne), periorbital (for wrinkles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Not Found
Summary of Performance Studies
The following tests were performed on the LYFT device and the test results show that the subject device is substantially equivalent to the predicate devices in the market.
| In Vitro Cytotoxicity | ISO 10993-5 for In Vitro Cytotoxicity standards |
|---|---|
| Skin Sensitization Test and Skin | |
| Irrititation Tests | ISO 10993-10 Tests for Irritation and Skin sensitization |
| Electromagnetic Compatibility Test | IEC 60601-1-2 standards |
| Electrical Safety and Essential | |
| Performance Test | IEC 60601-1; IEC 60601-2-57; IEC 60601-1-11 standards |
| Usability | IEC 62366-1 |
| Software Verification and Validation | |
| Test | FDA “Guidance for Pre Market Submissions and for Software |
| Contained in Medical Device” |
Key Metrics
Not Found
Predicate Device(s)
Ultra Renew Plus (K132833)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2018
Uplevity, Inc. % Marc Sanchez Regulatory Counsel Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave., Ste. 1025 Washington, District of Columbia 27517
Re: K180888
Trade/Device Name: LYFT 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: OLP Dated: August 1, 2018 Received: August 1, 2018
Dear Marc Sanchez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entiled, "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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180888
Device Name LYFT
Indications for Use (Describe) The LYFT device is intended to be used:
LED functional mode
To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face. To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
Micro Vibration functional mode
As an electrically powered device intended for medical purposes to relieve minor aches and pains.
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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3
UPLEVITY, Inc.
5. 510(K) Summary
The following information is provided as required by 21 CFR 807.92 for the LYFT 510(k) premarket notification.
| Applicant: | UPLEVITY, Inc.
40 Marshfield Rd
Niantic, CT 06357
Establishment Registration: 3013515062 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Shenzhen Perfect Idea Technology Co., Ltd.
4f, Building 1, Fuhua Industrial Park, Tangwei, Fuyong, Bao'an
Shenzhen Guangdong, 518103 CHINA
Establishment Registration: Awaiting Assignment of Registration Number |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC
53516 Bickett Chapel Hill NC 27517
Ph: 202.765.4491
E-mail: msanchez@fdaatty.com |
| Date of Submission: | August 29, 2018 |
| Proprietary Name: | LYFT |
| Common Name: | Over-The-Counter Powered Light Based Laser For Acne |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product Code: | OLP |
Predicate Device(s): Ultra Renew Plus (K132833)
Device Description:
The LYFT is a hand-held, rechargeable Li-Polymer battery powered device used for the treatment of mild to moderate acne, preorbital wrinkles, and the relief of minor aches and pains. The LYFT devices combines two (2) functional modes of operation, LED and micro vibration. The LED functional mode provides narrow bandwidth spectral output in the blue (430 ± 5 nm) and red (625 ± 5 nm) ranges. The micro vibration functional mode operates at a fixed frequency of 3 MHz ± 5%. The LYFT device uses a supplied power adaptor and is rechargeable.
4
UPLEVITY, Inc.
Intended Use: The LYFT device is intended to be used:
- LED functional mode
- O To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face.
- O To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
- Micro Vibration functional mode
- O As an electrically powered device intended for medical purposes to relieve minor aches and pains.
Summary of Non-Clinical Test Reports
The following tests were performed on the LYFT device and the test results show that the subject device is substantially equivalent to the predicate devices in the market.
| In Vitro Cytotoxicity | ISO 10993-5 for In Vitro Cytotoxicity standards |
|---|---|
| Skin Sensitization Test and Skin | |
| Irritation Tests | ISO 10993-10 Tests for Irritation and Skin sensitization |
| Electromagnetic Compatibility Test | IEC 60601-1-2 standards |
| Electrical Safety and Essential | |
| Performance Test | IEC 60601-1; IEC 60601-2-57; IEC 60601-1-11 standards |
| Usability | IEC 62366-1 |
| Software Verification and Validation | |
| Test | FDA “Guidance for Pre Market Submissions and for Software |
| Contained in Medical Device” |
Summary of Technological Similarities/Differences
The LYFT emits visible and/or infrared energy and micro vibration functional mode operates at a fixed frequency the same the Ultra Renew Plus. Both devices use similar outputs and have similar technical characteristics. The intended use is the same on both devices. There may be minor differences in labeling but this does not raise any new questions of safety or effectiveness.
| Technological Characteristics | ||
|---|---|---|
| Device Name/Model | LYFT | Ultra Renew Plus |
| 510(k) Number | t/b/d | K132833 |
Table 1
5
UPLEVITY, Inc.
Traditional 510k Submission LYFT
| Indication for Use | Full face wrinkles
and moderate to mild
acne. Relieve minor
aches and pains. | Full face wrinkles
and moderate to
mild acne. Relieve
minor aches and
pains. |
|-----------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Power Source | AC to DC and
Rechargeable battery | AC to DC |
| Wavelengths | 430 and 625nm | 450 and 650nm |
| Effective power for blue
and red LEd light | 0.9W and 0.8W | |
| Micro Vibration Function
Mode | 3 MHz ± 5% | 3 MHz ± 5% |
| Lightsource | LED/infrared bulbs | LED/infrared bulbs |
| Handheld | YES | YES |
Conclusion
Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the LYFT raises no different questions of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.