(88 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML for image processing, data analysis, or treatment parameter optimization.
Yes
The device is indicated for various medical treatments, including the treatment of Pseudofolliculitis Barbae (PFB), vascular lesions (e.g., port wine stains, hemangioma, rosacea), benign pigmented lesions (e.g., age spots, sun spots), and wrinkles. These are all therapeutic applications.
No
The device is a laser system used for treatments such as hair reduction, coagulation, hemostasis, and treatment of various skin lesions and wrinkles. It is not described as being used to diagnose conditions.
No
The device description clearly states it is a laser system comprised of a main body, optical fiber with handpiece, and footswitch, which are hardware components. While it mentions software for control, the core function and delivery of treatment are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for stable long-term or permanent hair reduction, treatment of PFB, and coagulation and hemostasis of various vascular and pigmented lesions, as well as wrinkle treatment. These are all therapeutic or aesthetic procedures performed directly on the patient's body.
- Device Description: The device is a laser system that emits energy to interact with tissue. This is consistent with a therapeutic or aesthetic device, not a device used to examine specimens in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the DermaV Laser System is a therapeutic/aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
1064 nm
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 mm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
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 (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 DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 mm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 532 nm or 1064 nm wavelength.
The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device.
The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch.
The DermaV laser system emits laser energy at 532 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.
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)
Nonclinical Performance Testing
The DermaV Laser System was tested for electrical safety and found to be in conformance with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and for electromagnetic compatibility and found to be in conformance with IEC 60601-1-2 Medical electrical equipment Part 1-2 General requirements for basic safety and essential performance- Collateral standard: Electromagnetic Disturbances-Requirements and tests.
The DermaV Laser System has been tested and found in conformance with IEC 60825-1 Safety of laser products-Part 1: Equipment classification and requirements.
The DermaV Laser System was tested for biocompatibility and is in conformance with ISO 10993-1 "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process ", ISO 10993-5 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ", and ISO 10993-10 "Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization".
Clinical Performance Testing
Clinical performance testing was not needed for this submission; therefore, no clinical tests were submitted.
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/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.
March 26, 2021
Lutronic Corporation Jhung Vojir Chief Operating Officer Lutronic Center. 219. Sowon-Ro Deogyang-Gu, Goyang-si, Geonggi-do 410220 Korea. South
Re: K203788
Trade/Device Name: DermaV Laser System 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 23, 2020 Received: December 28, 2020
Dear Jhung Vojir:
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/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 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 post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
For Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203788
Device Name DermaV Laser System
Indications for Use (Describe)
1064 nm
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 mm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
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 (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) |
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3
510(k) SUMMARY
Lutronic Corporation
DermaV Laser System
510(k) Owner
Lutronic Corporation 219, Sowon-Ro Deogyang-Gu, Goyang-Si, KR 410220
Submission Correspondent
Jhung Won Vojir, PhD Chief Operating Officer, Lutronic Aesthetics, Inc. 19 Fortune Drive Billerica, MA 01821 Tel: 888-588-7644
Date Prepared: March 24, 2021
Trade Name of Device
DermaV Laser System
Common or Usual Name Surgical Laser
Classification Name Laser Surgical Instrument for Use in General and Plastic Surgery and Dermatology: 21 C.F.R. 878.4810 Class II Product Code: GEX
Predicate Devices
Primary predicate: Lutronic Corporation CLARITY II cleared in K183566 Secondary predicate: Cutera Family of Coolglide Aesthetic Lasers cleared in K153671
Device Description
The DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 mm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 532 nm or 1064 nm wavelength.
The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device.
4
The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch.
The DermaV laser system emits laser energy at 532 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.
Indications for Use
1064 nm
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types. Fitzpatrick I - VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime.
The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated 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, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
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).
Nonclinical Performance Testing
The DermaV Laser System was tested for electrical safety and found to be in conformance with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and for electromagnetic compatibility and found to be in conformance with IEC 60601-1-2 Medical electrical equipment Part 1-2 General requirements for basic safety and essential performance- Collateral standard: Electromagnetic Disturbances-Requirements and tests.
5
K203788
The DermaV Laser System has been tested and found in conformance with IEC 60825-1 Safety of laser products-Part 1: Equipment classification and requirements.
The DermaV Laser System was tested for biocompatibility and is in conformance with ISO 10993-1 "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process ", ISO 10993-5 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ", and ISO 10993-10 "Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization".
Clinical Performance Testing
Clinical performance testing was not needed for this submission; therefore, no clinical tests were submitted.
Comparison with the Predicate Devices
The 1064 nm and 532 nm functionality of the DermaV Laser System utilizes technology similar to the predicate devices. The DermaV Laser System and the Lutronic CLARITY II Laser System have the same intended use and similar technological characteristics for the 1064 nm functions and the Cutera Coolglide Laser System has the same intended use and similar technological characteristics for the 532 nm functions. Performance testing provided demonstrates that the device can function safely and effectively for its intended use. Differences in the proposed device's technical features, such as software, biocompatibility, and laser output parameters, do not raise new types of questions regarding the device's safety and efficacy for its indications for use.
| Characteristic | DermaV Laser System | CLARITY II Laser System |
|---|---|---|
| Manufacturer | Lutronic Corporation | Lutronic Corporation |
| 510(k) Number | K203788 | K183566 |
| Product Code | GEX | GEX |
| Laser Wavelength | 1064 nm, 532 nm | 1064 nm, 755 nm |
| Indications for Use at 1064 nm | 1064 nm: The DermaV Laser | |
| System is indicated for stable | ||
| long term or permanent hair | ||
| reduction and for treatment of | ||
| PFB (Pseudofolliculitis Barbae) | ||
| on all skin types, Fitzpatrick I – | ||
| VI, including tanned skin. | ||
| Permanent hair reduction is | ||
| defined as the long-term, stable | ||
| reduction in the number of hairs | ||
| regrowing when measured at 6, 9, | ||
| and 12 months after the | ||
| completion of a treatment regime. |
The 1064 nm laser is also
indicated for coagulation and
hemostasis of soft tissue. for | 1064 nm: The DermaV Laser
System is indicated for stable
long term or permanent hair
reduction and for treatment of
PFB (Pseudofolliculitis Barbae)
on all skin types, Fitzpatrick I –
VI, including tanned skin.
Permanent hair reduction is
defined as the long-term, stable
reduction in the number of hairs
regrowing when measured at 6,
9, and 12 months after the
completion of a treatment
regime.
The 1064 nm laser is also
indicated for coagulation and |
| | | |
| | hemostasis of vascular lesions
such as but not limited to port
wine stains, hemangiomna, warts,
telangiectasia, rosacea, venus
lake, leg veins and spider veins.
The 1064 nm laser system is also
indicated 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,
(significant reduction in the
intensity of black and/or blue-
black tattoos) and plaques. The
1064 nm Laser is also indicated
for the treatment of wrinkles such
as, but not limited to, periocular
and perioral
wrinkles. | hemostasis of soft tissue, for
hemostasis of vascular lesions
such as but not limited to port
wine stains, hemangiomna,
warts, telangiectasia, rosacea,
venus lake, leg veins and spider
veins. The 1064 nm laser system
is also indicated 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, (significant
reduction in the intensity of
black and/or blue- black tattoos)
and plaques. The 1064 nm Laser
is also indicated for the
treatment of wrinkles such as,
but not limited to, periocular and
perioral
wrinkles. |
| Laser Type | Pulsed Solid State Laser | Pulsed Solid State Laser |
| Beam Delivery | Optical Fiber with Handpiece | Optical Fiber with Handpiece |
| Aiming Beam | 635 nm | 515-535 nm |
| Pulse Energy | 1064 nm: Max 100 J | 1064 nm: Max 100 J |
| Pulse Width | 0.1 - 60 ms | 0.1 - 300 ms |
| Max Fluence (J/cm2) | 300 | 600 |
| Pulse Rate | 0.5-10 Hz | 0.5-10 Hz |
| CDRH Laser Class | IV | IV |
| User Interface | Touch LCD | Touch LCD |
| Spot Size | 2, 3, 5, 7, 8, 10, 12, 14, 16 nm | 2, 3, 5, 8, 10, 12, 15, 16, 18, 20,
22, 24 nm |
| Emission Control | Finger Switch or Footswitch | Finger Switch or Footswitch |
| Integrated Cooling | Yes | Yes |
Table 1: DermaV Laser System Substantial Equivalence (1064 nm Functions)
6
Table 2: DermaV Laser System Substantial Equivalence (532 nm Functions)
| Characteristic | DermaV Laser System | Family of Coolglide Aesthetic Lasers |
|---|---|---|
| Manufacturer | Lutronic Corporation | Cutera, Inc. |
| 510(k) Number | K203788 | K153671 |
| Product Code | GEX | GEX |
| Laser Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm |
| Indications for Use at 532 nm | 532 nm | |
| For coagulation and hemostasis of | ||
| vascular and cutaneous lesions in | ||
| dermatology, including, but not | 532 nm | |
| For coagulation and hemostasis | ||
| of vascular and cutaneous | ||
| lesions in dermatology, |
7
| | 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). | 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). |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser Type | Pulsed Solid State Laser | Flash Pumped Solid State Rod |
| Beam Delivery | Optical Fiber with Handpiece | Optical Fiber with Handpiece |
| Aiming Beam | 635 nm | 630-680 nm |
| Pulse Energy | 532 nm: Max 13.5 J | 532 nm: Max 12 J |
| Pulse Width | 0.3 - 40 ms | 1.5 - 40 ms |
| Pulse Rate | 0.5-10 Hz | ≤ 10 Hz |
| Max Fluence (J/cm²) | 50 | 42 |
| CDRH Laser Class | IV | IV |
| User Interface | Touch LCD | Touch LCD |
| Spot Size | 2, 3, 5, 7, 8, 10, 12, 14, 16 nm | 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 nm |
| Emission Control | Finger Switch or Footswitch | Finger Switch or Footswitch |
| Integrated Cooling | Yes | Yes |
Conclusions
The DermaV Laser System's indications for use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to the predicates. Based on its technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the DermaV Laser System is considered to be substantially equivalent to the predicate devices.