(28 days)
Not Found
No
The summary describes a laser handpiece with a specific wavelength range and makes no mention of AI or ML technology in its description, intended use, or performance studies.
Yes
The device is used for the treatment of various benign pigmented and vascular lesions, which falls under therapeutic indications.
No
The device is described as a handpiece for the treatment of various benign pigmented and vascular skin lesions, not for diagnosing them.
No
The device description explicitly details hardware components like a console unit, footswitch, handpieces, power supply modules, cooling system, and an isolation transformer. The submission focuses on modifications to a handpiece, which is a physical component.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description and intended use clearly indicate that the Dye VL Handpiece is a light-based device used for the treatment of various skin lesions and conditions. It directly interacts with the patient's skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on laboratory tests.
The device is a therapeutic device used for dermatological treatments.
N/A
Intended Use / Indications for Use
The Dye VL Handpiece (500-600 nm) is indicated for:
- The treatment of benign pigmented lesions including café -au-lait (macules), lentigines ● (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
- The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, ● and plaques.
- . 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.
- Use on skin types (Fitzpatrick I-V). ●
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
- . Software verification and validation was performed, and demonstrates that the software performs as intended.
- . Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established.
- Biocompatibility of patient-contacting components was established per ISO 10993. .
In all instances, the subject device functions as intended and meets all the same acceptance criteria as the 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 13, 2018
Alma Lasers Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K181298
Trade/Device Name: Harmony XL Multi-Application Platform 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: May 16, 2018 Received: May 16, 2018
Dear Janice Hogan:
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 device-related adverse events) (21 CFR 803); good
1
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.
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 medical devices and radiation-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.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K181298
Device Name
Harmony XLTM Multi-Application Platform (with the Dye VL Handpiece)
Indications for Use (Describe)
The Dye VL Handpiece (500-600 nm) is indicated for:
- The treatment of benign pigmented lesions including café -au-lait (macules), lentigines ● (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
- The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, ● and plaques.
- . 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.
- Use on skin types (Fitzpatrick I-V). ●
Type of Use (Select one or both, as applicable)
2 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 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 267PRAStaff@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 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
3
510(k) SUMMARY - K181298
Alma Lasers, Inc.'s Harmony XL™ Multi-Application Platform
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Rekha Anand, Senior Regulatory Affairs Associate Alma Lasers, Inc. 485 Half Day Rd. Suite #100 Buffalo Grove, Illinois, 60089
Phone: 224-377-2000 (Ext 2019) Email: Rekha.Anand@almalasers.com
Date Prepared: June 6, 2018
Name of Device
Harmony XL™ Multi-Application Platform
Common or Usual Name
Intense Pulsed Light Instrument
Classification
21 CFR 878.4810, Class II, product code ONF
Predicate Devices
- Harmony XL™ Multi-Application Platform and Thermoelectric Cooler (K072564) ● (Primary Predicate)
- . Alma Harmony Lite (K141237) (Predicate)
Intended Use / Indications for Use
The Dye VL Handpiece (500-600 nm) is indicated for:
- O The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma. nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
- The treatment of other pigmented cutaneous lesions including verrucae, skin tags, o keratosis, and plaques.
- The treatment of benign cutaneous vascular lesions including port wine stains, o hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
4
- o Use on skin types (Fitzpatrick I-V).
Device Description
The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.
Comparison of Technological Characteristics
The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.
With regard to indications for use, the intended use/indications for use of the Dye VL handpiece are the same as the primary and secondary predicate devices. Specifically, the Dye VL handpiece consists of a subset of the indications for use of the 532 nm Long Pulsed and Q-Switched FD Nd: YAG Laser Module Handpiece ("532 nm handpiece") included in the primary predicate. Both the subject handpiece and the 532 nm handpiece are indicated for the treatment of benign pigmented lesions including café-au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, Becker's Nevi and other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. Further, the indications for use of both the subject Dye VL handpiece and the SVL515 included in both the primary and secondary predicate device are indicated for 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 and are indicated to be used on skin types Fitzpatrick I-V. Therefore, the indications for use of the subject device are the same as its predicates.
Performance Data
- . Software verification and validation was performed, and demonstrates that the software performs as intended.
- . Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established.
- Biocompatibility of patient-contacting components was established per ISO 10993. .
In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices.
Substantial Equivalence
The Harmony XLT™ has the same intended use/indications for use, as well as very similar
5
technological characteristics, and identical principles of operation as its predicate devices. The minor technological differences between the subject and predicate devices do not raise new questions of safety or effectiveness.
Conclusion
The minor technological differences between the subject and predicate devices do not raise new or different questions of safety or effectiveness. Design verification activities demonstrated that the device performs as intended and thus is substantially equivalent.