(66 days)
Not Found
No
The summary describes a light therapy device with specific wavelengths and power outputs. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities.
Yes
The device is indicated for the "treatment of periorbital wrinkles" and "treatment of mild to moderate acne," which are therapeutic applications.
No
The device description and intended uses clearly state that LMNT O2 emits light for treatment of periorbital wrinkles and acne, not for diagnosis of conditions. It describes therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is a "hand held device that uses low power light spectrum at red and infrared LED" and "also uses blue LED," indicating it is a hardware device that emits light, not a software-only device.
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 the device is used for the "treatment of periorbital wrinkles" and "treatment of mild to moderate acne." These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a hand-held device that emits light energy for treatment purposes. It does not mention any components or processes related to analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Keywords: The document does not contain any keywords typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis," "sample," "reagent," etc.
IVDs are devices 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 function is to directly treat conditions using light energy.
No.
The clearance letter explicitly states "Not Found" under the "Predetermined Change Control Plan (PCCP)" section, indicating that this device was not authorized under a PCCP.
Intended Use / Indications for Use
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
LMNT O2 is a hand held device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±15nm, 830 ±15nm distribution with no hot spots for the treatment of periorbital wrinkles. The device also uses blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots for the treatment of acne. Designed for home-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire face and periorbital area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed, including Electrical safety, EMC, Additional safety testing, Biocompatibility testing, and Performance testing (Skin Temperature Testing, LED Wavelength and Power Density Testing, No hot spots Testing). The conclusion from the non-clinical tests demonstrates that the subject device is as safe as the legally marketed predicate devices.
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.
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
§ 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.
FDA 510(k) Clearance Letter - LMNT O2
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
March 24, 2025
XPLR Ltd.
℅ Doris Dong
Shanghai CV Technology Co., Ltd.
Room 805, No. 19 Dongbao Road, Songjiang Area, Shanghai
201613 China
Shanghai, 201613
China
Re: K250125
Trade/Device Name: Lmnt O2
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: OHS, OLP
Dated: January 15, 2025
Received: January 17, 2025
Dear Doris Dong:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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.
March 24, 2025
XPLR Ltd.
℅ Doris Dong
Shanghai CV Technology Co., Ltd.
Room 805, No. 19 Dongbao Road, Songjiang Area, Shanghai
201613 China
Shanghai, 201613
China
Re: K250125
Trade/Device Name: Lmnt O2
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: OHS, OLP
Dated: January 15, 2025
Received: January 17, 2025
Dear Doris Dong:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K250125 - Doris Dong Page 2
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
Page 3
K250125 - Doris Dong Page 3
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.03.24 23:53:11 -04'00'
Page 4
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)
K250125
Device Name
LMNT O2
Indications for Use (Describe)
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K250125
Device Name
LMNT O2
Indications for Use (Describe)
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary #K250125
[As required by 21 CFR 807.92]
1. Submission Information
510(k) Number:
Date: January 15, 2025
Type of 510(k) Submission: Traditional 510(k)
Basis for 510(k) Submission: New device
Owner:
XPLR ltd
Ben ami 6 st, Tel Aviv, Israel
Tel: +972-52-4200400
Email: Info@xplr-med.com
Website: www.Xplr-med.com
Contact:
Doris Dong
[Consultant, from Shanghai CV Technology Co., Ltd.]
Add: Room 805, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China
E-mail: doris.d@ceve.org.cn
Tel: 86 21-31261348 / Fax: 86 21-57712250
2. Device Description
Proprietary Name: LMNT O2
Classification Name: Light Based Over The Counter Wrinkle Reduction, Over-The-Counter Powered Light Based Laser For Acne
Regulation Number: 21 CFR 878.4810
Product Code: OHS,OLP
Device Class: II
Review Panel: General & Plastic Surgery
Device Description:
LMNT O2 is a hand held device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±15nm, 830 ±15nm distribution with no hot spots for the treatment of periorbital wrinkles. The device also uses blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots for the treatment of acne. Designed for home-use.
Indications for use:
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.
3. Predicate Device Identification
Predicate 510(k) Number: K232656
Marketing clearance date: 11/14/2023
Product name: BLU TOTALE (Model: ENEOB852)
Manufacturer: Premier North America Inc.
Predicate 510(k) Number: K181659
Marketing clearance date: 07/26/2018
Page 6
Product name: Avologi ENEO
Manufacturer: Premier North America Inc.
Page 7
4. Substantial Equivalence to Predicate device
| New Device | Predicate Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 510(k) Number | To be assigned | K232656 | K181659 | -- |
| Proprietary Name | LMNT O2 | BLU TOTALE | Avologi ENEO | -- |
| Model | -- | ENEOB852 | -- | -- |
| Owner | XPLR ltd. | Premier North America Inc. | Premier North America Inc. | -- |
| Product Code | OHS,OLP | OLP | OHS | Same |
| Classification | II | II | II | Same |
| Indications for use | LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne. | BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne. | Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. | Same |
| Type | Hand-held | Hand-held | Hand-held | Same |
| Materials | Rigid ABS and stainless steel | Rigid ABS and stainless steel | Rigid ABS and stainless steel | Same |
| Target Population | Individuals with periorbita wrinkles and mild to moderate acne on the face. | Individuals with mild to moderate acne on the face. | Individuals with periorbita wrinkles | Same |
| Anatomical Sites | Entire face and periorbital area | Entire Face | Periorbital Area | Same |
| Light source | Light emitting diode (LED) | Light emitting diode (LED) | Light emitting diode (LED) | Same |
| Light spectrum region | Blue light,red and IR region of the spectrum | Blue light | red and IR region of the spectrum | Same |
| Wavelengths | 633 ±15nm, 830 ±15nm,415±15nm | 415±15nm | 633 ±5nm, 830 ±5nm | Same |
| Waveform | Constant | Constant | Constant | Same |
| Visible light LEDs | Yes | Yes | Yes | Same |
Page 8
| New Device | Predicate Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Energy source | 36 pcs LEDs(12pcs 633nm LEDs + 12pcs 830nm LEDs+ 12pcs 415nm LEDs)over 10cm2 | 24 pcs LEDs over 15cm2 | 24 pcs LEDs (12pcs 633nm LEDs + 12pcs 830nm LEDs ) over 15cm2 | Similar |
| Energy density | 69mW/cm2 for 633nm 53mW/cm2 for 830nm 49mW/cm2 for 415nm | 50mW/cm2 | 69mW/cm2 for 633nm 55mW/cm2 for 830nm | Similar |
| Initial treatment course | Red light mode: For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes each time (5-7 minutes on each treatment zone). Blue light mode: 4 minutes per area, twice per week for 4 weeks (total of 8 treatments). | 4 minutes per area, twice per week for 4 weeks (total of 8 treatments) | For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes each time (5-7 minutes on each treatment zone). | Same |
| Power supply | Lithium battery | Lithium battery | Lithium battery | Same |
5. Non-clinical Testing
The LMNT O2 has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
EMC:
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
Additional safety testing:
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment;
- IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems;
Page 9
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
Biocompatibility testing:
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity;
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation;
Performance testing:
- Skin Temperature Testing
- LED Wavelength And Power Density Testing
- No hot spots Testing
6. Conclusions
The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K232656 and K181659.