(272 days)
K173846 DermaScalp Laser Cap
No
The summary describes a laser system with different handpieces for various dermatological and aesthetic treatments. The device description focuses on hardware components (power supply, laser module, control unit, PC module, handpiece with scanner and mirrors). There is no mention of AI, ML, image processing, or any software features that would suggest the use of such technologies for analysis, decision-making, or treatment guidance. The clinical studies evaluate the device's efficacy based on hair count and blinded reviewer assessment, not on the performance of an AI/ML algorithm.
Yes.
The device is intended for various medical and aesthetic treatments, including the treatment of skin lesions, vascular lesions, acne, and for hair reduction and improvement of scalp hair appearance, which are therapeutic applications.
No
The device is described as a treatment device, with multiple handpieces for various aesthetic and dermatological skin procedures, including hair removal, treatment of lesions, and hair reduction/improvement. It does not perform diagnostic functions.
No
The device description clearly states it is a "Laser System" and includes physical components like a power supply unit, laser module, control unit, PC module, handpiece with scanner module and mirrors, and a tip. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to treating various skin conditions, removing unwanted hair, and improving the appearance of scalp hair. These are all procedures performed directly on the patient's body.
- Device Description: The device is a laser system that delivers energy to the target tissue. This is a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
- o Cutaneous lesions, including warts, scars and striae
- o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o Mild to moderate inflammatory Acne (Acne vulgaris)
The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for:
- o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o The non-ablative treatment of facial wrinkles
The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:
- o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
- o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF, ONG
Device Description
The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):
- The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
- . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
- . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).
The F65 is intended for professional use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, scalp, hair follicles, facial, truncal, leg
Indicated Patient Age Range
Adult males and females (specifically for scalp hair treatment)
Intended User / Care Setting
Clinic Use by professional operator
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
Two clinical studies were conducted to demonstrate that the subject device is safe and effective in patients seeking treatment for hair loss, as indicated.
In a prospective, single arm study, 32 subjects with hair loss were enrolled, 25 of which completed the entire course of the study.
In a second retrospective single arm study, a total of 98 subjects were evaluated for performance, with ages ranging from 21 to 66 years and a mean age of 37.2 ± 9.9 years.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A preclinical study was conducted to evaluate the Lumenis F65 subject module for hair follicle regeneration capabilities using both Low Level Laser Therapy (LLLT) and untreated controls. The results showed complete tissue repair and formation of hair follicles.
Two clinical studies were conducted to demonstrate that the subject device is safe and effective in patients seeking treatment for hair loss, as indicated. Subjects received multiple treatments over several months, per the protocol described in the Operator's Manual.
In a prospective, single arm study, 32 subjects with hair loss were enrolled, 25 of which completed the entire course of the study. Patients were diagnosed with Androgenic Alopecia (18) or other diagnosis (7) and were evaluated separately. In the Androgenic Alopecia group, the mean age was 32.1 ± 6.4 years. Most of the subjects were female (13/18) and all subjects included were of Fitzpatrick skin type II. For male subjects with androgenic alopecia (n=5) there was an increase of 70.8 ± 35.5 hairs per cm² between baseline and the 3-month follow-up visit. For female subjects with androgenic alopecia (n=18) there was an increase of 45.2 ± 30.2 hairs per cm² between baseline and 3-month follow-up visit. Pain and discomfort during treatment were assessed with a visual analog scale (VAS) and ranged between 1.97 to 2.33 on a scale from 0 to 10. Post treatment subjects had a trace to mild erythema. No adverse events were reported during the study treatment or follow-up period.
In a second retrospective single arm study, a total of 98 subjects were evaluated for performance, with ages ranging from 21 to 66 years and a mean age of 37.2 ± 9.9 years. Of them, in 44 (44/98, 44.9%) of the cases the documented diagnosis was Androgenic Alopecia, and in 54 cases (54/98, 55.1%) there was no documented diagnosis. Females slightly outnumbered males (51 vs. 47), and the majority of subjects had Fitzpatrick skin type III (60/98, 61.2%), with some having skin types II (18/98, 18.4%) or IV (1/98, 1%). All patient records were reviewed for any reports of adverse events during treatment or follow-up period – no adverse events were reported or documented in patient files. For the 44 subjects with a confirmed diagnosis of androgenic alopecia, the assessment of improvement in scalp hair appearance yielded a correct identification in 97.7% (95% Cl: 87.8% -99.7%) of the cases by a group of 3 blinded reviewers. Demonstrating improvement in scalp hair appearance in more than 85% of the patients treated which supports the primary efficacy endpoint of demonstrating improvement in more than 70% of subjects. For the 98 subjects included in the performance analysis, the assessment of improvement in scalp hair appearance yielded a correct identification in 96.9% (95% CI: 91.38 -98.5%) of the cases by a group of 3 blinded reviewers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective study:
Male subjects with androgenic alopecia (n=5): increase of 70.8 ± 35.5 hairs per cm²
Female subjects with androgenic alopecia (n=18): increase of 45.2 ± 30.2 hairs per cm²
Pain and discomfort (VAS): 1.97 to 2.33 on a scale from 0 to 10.
Retrospective study:
For the 44 subjects with a confirmed diagnosis of androgenic alopecia, the assessment of improvement in scalp hair appearance yielded a correct identification in 97.7% (95% Cl: 87.8% -99.7%)
For the 98 subjects included in the performance analysis, the assessment of improvement in scalp hair appearance yielded a correct identification in 96.9% (95% CI: 91.38 -98.5%)
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.
K193500 (Lumenis Stellar M22)
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.
K173846 DermaScalp Laser Cap
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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June 14, 2023
Lumenis Be, Ltd. Shlomit Segman Senior Director RA 6 Hakidma Street PO BOX 240 Yokneam, Yokneam 2069204 Israel
Re: K222790
Trade/Device Name: F65 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: GEX, ONF, ONG Dated: Mav. 2023 Received: May 5, 2023
Dear Shlomit Segman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
Jianting Wang -S
Jianting Wang Acting 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
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Indications for Use
510(k) Number (if known) K222790
Device Name F65 Laser System
Indications for Use (Describe)
The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
- o Cutaneous lesions, including warts, scars and striae
- o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o Mild to moderate inflammatory Acne (Acne vulgaris)
The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for:
- o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o The non-ablative treatment of facial wrinkles
The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:
- o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
- o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
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X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) SUMMARY K222790-S001
F65 Laser System and Accessories
| Applicant Name: | Lumenis Be Ltd.
9 Hakidma Street PO Box 426
Yokneam Industrial Park,
Yokneam 2069236, Israel
Tel: +972-77-9599000 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shlomit Segman, Lumenis Be Ltd.
9 Hakidma Street PO Box 426
Yokneam Industrial Park,
Yokneam 2069236, Israel
Tel: +972-77-9599230
Email:Shlomit.Segman@lumenis.com |
| Date Prepared: | June, 2023 |
| Trade Name: | F65 Laser System and Accessories |
| Common Name: | Powered Laser Surgical Instrument With Microbeam\Fractional Output |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology. |
| Product Code: | GEX, ONF, ONG |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4810 |
| Panel: | General & Plastic Surgery |
| Predicate Devices: | K193500 (Lumenis Stellar M22)
Reference: K173846 DermaScalp Laser Cap |
Intended Use/ Indications for Use:
The subject F65 Laser System has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
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The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
- o Cutaneous lesions, including warts, scars and striae
- o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leq telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leq veins and venous malformations
- o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o Mild to moderate inflammatory Acne (Acne vulgaris)
The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
- o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- o The non-ablative treatment of facial wrinkles
The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:
- o Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
- o Improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
- o Removal of dark tattoos
- o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
6
Device Description
The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):
- The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
- . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
- . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).
The F65 is intended for professional use only.
Substantial Equivalence Discussion
The key difference between the Lumenis Be F65 Laser System and its predicate is the new indication for improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, which has led to this 510(k). While the F65 Laser System delivers the same light wavelength as the predicate, the intensity and pattern of the delivered light to the scalp are specific to the proposed new indication.
Promoting hair growth through exposure to light is not a new concept, as demonstrated by the clearance of the reference device and other devices under the same classification as the reference device.
Safety questions associated with electrical, electromagnetic compatibility, and biocompatibility, are addressed through testing conducted on the predicate device. Animal testing of the subject device's operating parameters addresses both safety and effectiveness questions for the new proposed indication. Likewise, the safety and effectiveness of the device for the proposed indication were also evaluated through two clinical studies of patients seeking treatment for hair loss.
Table 1 provides a comparison, relevant to the F65 module with the 1565 nm laser, which is related to the new proposed indication, of the technical characteristics of the subject device to its predicate and reference devices.
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| Parameter | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| F65 Laser module System | Stellar M22 1565 nm module | ||
| (K193500) | DermaScalp Laser Cap (K172846) | ||
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 890.5500 |
| Procode | GEX, ONF, ONG | GEX, ONF, ONG | OAP |
| Rx/OTC | Rx | Rx | OTC |
| Indications for Use | The F65 module and | ||
| handpiece, with wavelength of | |||
| 1565 nm, are indicated for: | |||
| • Use in dermatological | |||
| procedures requiring | |||
| fractional skin resurfacing | |||
| and coagulation of soft tissue | |||
| • Improving the appearance of | |||
| scalp hair in adult males and | |||
| females with Fitzpatrick skin | |||
| type I to IV who are seeking | |||
| treatment for hair loss. | The 1565 nm Stellar M22 | ||
| Module & Handpiece, with | |||
| wavelength of 1565 nm is | |||
| indicated for use in | |||
| dermatological procedures | |||
| requiring fractional skin | |||
| resurfacing and coagulation of | |||
| soft tissue. | The family of DermaScalp Laser | ||
| Cap devices are indicated to treat | |||
| Androgenetic Alopecia and promote | |||
| hair growth in Males who have | |||
| Norwood Hamilton Classifications of | |||
| Ila to V patterns of hair loss and to | |||
| treat Androgenetic Alopecia and | |||
| promote hair growth in Females | |||
| who have Ludwig (Savin) Scale I-1 | |||
| to I-4, II-1, II-2, or frontal; both with | |||
| Fitzpatrick Skin Types I to IV. | |||
| Device | |||
| Configuration | System console and handpiece | System console and handpiece | Power supply and laser diode caps |
| Wavelength | 1565 nm | 1565 nm | 650 nm |
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| Type of Laser | Er:Glass Fiber-laser with
scanner up to 500 micro-
beams per cm² | Er:Glass Fiber-laser with
scanner up to 500 micro-beams
per cm² | Diode lasers at count of - 50, 80,
120, 148, 180, 202, 224, 272 |
|-----------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy | Up to 70 mJ per microbeam | Up to 70 mJ per microbeam | Total Laser Energy: