(26 days)
Not Found
No
The provided text describes a laser system for surgical and aesthetic applications and does not mention the use of AI, DNN, or ML in its design or operation.
Yes
The device is described as a laser system intended for use in various surgical and aesthetic applications to treat specific medical conditions such as benign vascular lesions, pigmented lesions, wrinkles, acne, and hair reduction. These applications directly relate to the treatment or mitigation of diseases, injuries, or conditions, classifying it as a therapeutic device.
No
The device is described as a laser system intended for "surgical and aesthetic applications" such as coagulation, hemostasis, and treatment of various lesions and conditions. Its functionality involves delivering laser energy to tissue, not analyzing biological data for diagnostic purposes.
No
The device description explicitly details physical hardware components and the delivery of energy through an optical fiber and handpiece. It is clearly a hardware-based laser system.
No
IVD devices are used to examine specimens derived from the human body, while this device is a laser system used for surgical and aesthetic applications directly on the body.
N/A
Intended Use / Indications for Use
The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
Dermatology:
The Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Product codes
GEX
Device Description
The Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (up) and/or (down) button.
The selectable fluence values are 2 to 300 J/cm² at 1064 nm and 1.8 to 42 J/cm² at 532 nm.
Fluence[J/cm²] = Energy [J]/((Spot Size/2[cm])² * 3.14).
Laser output is limited by software depending on the selected spot size (2 – 12 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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 Test Summary: The Alma Veil has been tested for conformance to the performance standards: AASI AAMI ES60601-1:2005/(R)2012 and A1:2012, ANSI AAMI IEC 60601-1-2:2014, IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22 Edition 4 2014, and IEC 60825-1:2014 (Third Edition).
Software Validation: The Alma Veil contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005).
Biocompatibility: The handpiece tip is made of Stainless Steel and Sapphire Window, with intact skin patient contact for limited duration (
§ 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 - Alma Veil Laser System
Page 1
April 6, 2025
Won Tech Co., Ltd.
Hyun Sik Yoon
General Manager
64 Techno8-ro 64, Yuseong-gu
Daejeon, 34028
Korea, South
Re: K251094
Trade/Device Name: Alma Veil
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: April 7, 2025
Received: April 10, 2025
Dear Hyun Sik Yoon:
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.
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
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K251094 - Hyun Sik Yoon Page 2
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-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Page 3
K251094 - Hyun Sik Yoon Page 3
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 L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.05.06 17:59:10 -04'00'
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251094
Device Name: Alma Veil
Indications for Use (Describe)
The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
Dermatology:
The Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
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.
Page 5
FORM FDA 3881 (8/23) Page 2 of 2
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."
Page 6
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 1 / 10
510(k) Summary: K251094
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
2025.04.07
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
- Name of Manufacturer: WON TECH Co., Ltd.
- Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea
- Contact Name: Hyun Sik Yoon
- Telephone No.: +82-10-6750-5346
- Fax No.: +82-70-7836-0110
- Email Address: yoonhs21@wtlaser.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Common name: Powered Laser Surgical System
Trade name: Alma Veil
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Powered Laser Surgical Instrument | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic types of device has been classified as Class II.
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64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 2 / 10
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow:
Predicate device
- 510(k) Number: K231054
- Applicant: WON TECH Co., Ltd.
- Classification Name: Powered Laser Surgical Instrument
- Trade Name: V-Laser
5. Description of the Device [21 CFR 807.92(a)(4)]
The Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (up) and/or (down) button.
The selectable fluence values are 2 to 300 J/cm² at 1064 nm and 1.8 to 42 J/cm² at 532 nm.
| Wavelength | 1064 nm | 532 nm | Genesis Mode |
|---|---|---|---|
| Fluence Value(J/cm²)* | 0.2 - 10.0** | 0.1 - 2.5** | 4 – 7** |
The formula used to calculate the fluence is as follows:
*Fluence[J/cm²] = Energy [J]/((Spot Size/2[cm])² * 3.14).
** Laser output is limited by software depending on the selected spot size (2 – 12 mm).
6. Indications for Use [21 CFR 807.92(a)(5)]
The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
Dermatology:
Page 8
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 3 / 10
The Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
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64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 4 / 10
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between Alma Veil and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device | SE Decision | |
|---|---|---|---|
| K Number | - | K231054 | - |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | - |
| Model | Alma Veil | V-Laser | - |
| Intended Use | The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. | The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. | Same |
| Anatomical site | Skin and subcutaneous tissue | Skin and subcutaneous tissue | Same |
| Principle/Method of Operation | The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. |
1064 nm:
Dermatology:
The Alma Veil is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. | The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
Dermatology:
The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. | Same |
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TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 5 / 10
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm:
| Alma Veil | V-Laser |
|---|---|
| Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. |
The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The V-Laser is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The V-Laser is also indicated for the treatment for pseudofolliculitis barbae.
The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm: | Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm: |
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64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 6 / 10
| Alma Veil | V-Laser |
|---|---|
| For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). | For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). |
| Parameter | Alma Veil | V-Laser | SE Decision |
|---|---|---|---|
| Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm | Same |
| Repetition Rate | Max. 10 Hz | Max. 10 Hz | Same |
| Laser Media | Flashlamp-pumped solid state rod | Flashlamp-pumped solid state rod | Same |
| Aiming Beam | 635 nm | 635 nm | Same |
| Color of Main Unit* | [Dark gray unit image] | [White unit image] | Different |
| The color has been changed into darkish gray, due to the marketing strategy of the manufacturer. | |||
| Color of Handpiece* | [Dark gray handpiece image] | [White handpiece image] | Different |
| The color has been changed into darkish gray, due to the marketing strategy of the manufacturer. |
Page 12
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 7 / 10
| Parameter | Alma Veil | V-Laser | SE Decision |
|---|---|---|---|
| Handpiece tip holder* | [Image of handpiece tip holder] | [Image without tip holder] | Different |
| The Handpiece tip holder has been added, due to the marketing strategy of the manufacturer. | |||
| Fiber cable type* | [Image of mesh-type cable] | [Image of standard cable] | Different |
| The Fiber cable type has been changed into Mesh-type, due to the marketing strategy of the manufacturer. | |||
| GUI* | [Image of new GUI interface] | [Image of V-Laser GUI] | Different |
| The GUI has been changed, due to the marketing strategy of the manufacturer. | |||
| Color of Foot Switch* | [Image of black foot switch] | [Image of white foot switch] | Different |
| The Foot Switch Color has been changed, due to the marketing strategy of the manufacturer. |
Page 13
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 8 / 10
| Parameter | Alma Veil | V-Laser | SE Decision |
|---|---|---|---|
| Power Supply / Plug Specification* | 220–230V~, 60Hz, NEMA L6-20P plug type | 220–230V~, 60Hz, IEC 60884-1 type plug (Model: KKP-4819R) | Different |
| Electrical rating unchanged, plug type modified for local market, due to the marketing strategy of the manufacturer. |
Page 14
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 9 / 10
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) The Alma Veil has been tested for conformance to the performance standards in the following table:
| Standard (Edition) | Standard Title |
|---|---|
| AASI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 Edition 3.1 2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-22 Edition 4 2014 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60825-1:2014 (Third Edition) | Safety of laser products - Part 1: Equipment classification and requirements |
2) Software Validation
The Alma Veil contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005)
3) Biocompatibility
| Part | Material | Patient Contact | Duration of Contact by ISO 10993-1 | Biocompatibility |
|---|---|---|---|---|
| Handpiece Tip | Stainless Steel | |||
| Sapphire Window | Intact Skin | Limited | ||
| ( |