(28 days)
No
The summary describes a laser device with different wavelengths and configurations for various dermatological treatments. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on biocompatibility, electrical safety, software validation, and usability, without any indication of AI/ML model performance evaluation.
Yes
The device's intended uses include treatment of various medical conditions, such as port-wine stains, hemangioma, rosacea, onychomycosis, and the reduction of red pigmentation in hypertrophic and keloid scars, which are therapeutic applications.
No
Explanation: The device description and intended use clearly state that the device is a laser system used for treatments such as hair removal, photocoagulation, and treatment of various skin lesions and conditions. There is no mention of it being used for diagnosis, detection, assessment, or monitoring of any medical condition or disease.
No
The device description explicitly states it is a laser equipped with solid-state laser sources and describes different hardware configurations (Alexandrite and/or Nd:YAG crystals). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions or performing procedures directly on the patient's body (hair removal, treatment of skin lesions, wrinkle reduction, etc.). IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a laser system that emits light at specific wavelengths to interact with tissues. This is consistent with a therapeutic or surgical device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Splendor X laser device, as described, falls under the category of a therapeutic or surgical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nd:YAG 1064 Laser is intended for:
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
- Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis of soft tissue.
- Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).
The Alexandrite 755 laser is intended for:
- Temporary hair reduction.
- Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I - VI, including tanned skin.
- Treatment of benign pigmented lesions.
- Treatment of wrinkles.
- Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Product codes
GEX
Device Description
The Splendor X (Alex, Alex², Nd:YAG, Alex + Nd: YAG), hereinafter referred to as "Splendor X", is a laser equipped with one or two solid-state laser sources. The 4 configurations differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm:
- Alex configuration has only one source and one wavelength available (755 nm).
- Alex² configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available.
- Nd:YAG configuration has only one source and one wavelength available (1064 nm).
- In the Alex+Nd:YAG configuration has both the two wavelengths available (755 nm and 1064 nm). In this configuration the two wavelengths can act only individually, simultaneous operations are not allowed. This configuration works with three different modes: only with Alex source, only with Nd:YAG source or in the BlendX mode. With the BlendX mode, an initial pulse with Alexandrite source is followed automatically, without overlapping in time, by another pulse of the Nd:YAG source.
This device is intended for medical use only.
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)
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility Testing: The biocompatibility evaluation of the Splendor X device was conducted, and documentation was provided in accordance with the FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and the recognized consensus standard ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Splendor X device is categorized as "surface device", "intact skin" contact, and "limited" contact 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2024
Bios S.r.l. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K241407
Trade/Device Name: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) 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: May 17, 2024 Received: May 17, 2024
Dear Prithul Bom:
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 (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/cdrb/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
1
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 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-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 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.
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-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).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-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. Digitally signed by Hithe -S - Date: 2024.06.1
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
3
Indications for Use
Submission Number (if known)
Device Name
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
ndications for Use (Describe)
The Nd:YAG 1064 Laser is intended for:
-
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
-
Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
-
Coagulation and hemostasis of soft tissue.
-
Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
-
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
-
Treatment of wrinkles.
-
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes,
Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).
The Alexandrite 755 laser is intended for:
-
Temporary hair reduction.
-
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I - VI, including tanned skin.
-
Treatment of benign pigmented lesions.
-
Treatment of wrinkles.
-
Photocoagulation of dermatological benign vascular lesions (such as port-wine stains,
hemangiomas, telangiectasias).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
er-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
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Image /page/4/Picture/1 description: The image shows the logo for "bios, A LUMENIS COMPANY". The word "bios" is written in a simple, sans-serif font, with the letters in a dark blue color. Below the word "bios", in a smaller font size, is the text "A LUMENIS COMPANY", also in dark blue. The logo is clean and modern in appearance.
Electronic Submission Template And Resource (eSTAR)
510kSummary - K241407
Complying with 21 CFR 807.92
I. Submitter
Bios S.r.l. Via Guido Rossa 10/12 20055 Vimodrone (MI) – Italy
Phone: +39 02 27304275 Mobile: +39 391 7461002 Fax: +39 02 27304276 Email: m.deiturbe@biosgroup.eu
Contact Person: Dr. Martina De Iturbe Date prepared: 11th June 2024
ll. Device
| Device Proprietary Name: | Splendor X (Alex, Alex², Nd: YAG, Alex + Nd: YAG) |
|---|---|
| Device Common Name: | Powered laser surgical instrument |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and |
| in dermatology (21 CFR 878.4810) | |
| Regulatory Class: | II |
| Product Code: | GEX |
III. Predicate/Reference Device
The substantial equivalence is based on the following Predicate Device:
| Trade Name | Product Code and
classification regulation | Manufacturer | 510(k) Number |
|-------------------------------------------------------------|-----------------------------------------------|--------------|---------------|
| Family of Square Epil (Alex, Alex2,
Nd:YAG, Alex+Nd:YAG) | GEX
21 CFR 878.4810 | Bios S.r.l. | K161632 |
The Predicate device has been evaluated by the manufacturer as adequate for the equivalence comparison purposes and it has been detected using the best practices for selecting the predicate device. The predicate device has been firstly identified on the basis of the same intended use and the regulatory framework and basic administrative information (classification, medical device class, product code, and applicable federal regulation etc..) that are the same as the subject device. Secondary, a predicate device identifying well-established safety and performance testing has been preferred to others with lower information availability. The predicate device is currently marketed in
5
Image /page/5/Picture/1 description: The image shows the logo for "bios, A LUMENIS COMPANY". The word "bios" is written in a lowercase, sans-serif font with rounded edges, and the letters are connected. The color of the word is a dark blue. Below the word "bios" is the text "A LUMENIS COMPANY" in a smaller, sans-serif font, also in dark blue.
the US and all the documentation is available to support the equivalence since Bios is the manufacturer of the predicate device as well.
In the end, a predicate device with a negligible rate of serious malfunctions/serious injuries/deaths, without unmitigated safety issues and no recalls has been chosen.
Furthermore, the following Reference Device has been identified to support the difference in the technological characteristics between the subject device and the selected predicate device.
| Trade Name | Product Code and
classification regulation | Manufacturer | 510(k) Number |
|--------------------|-----------------------------------------------|------------------------|---------------|
| GentleMax Pro Plus | GEX
21 CFR 878.4810 | Candela
Corporation | K201111 |
IV. Device Description
The Splendor X (Alex, Alex , Nd:YAG, Alex + Nd: YAG), hereinafter referred to as "Splendor X", is a laser equipped with one or two solid-state laser sources.
The 4 configurations differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm:
- Alex configuration has only one source and one wavelength available (755 nm).
- . Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available.
- Nd:YAG configuration has only one source and one wavelength available (1064 nm).
- . In the Alex+Nd:YAG configuration has both the two wavelengths available (755 nm and 1064 nm). In this configuration the two wavelengths can act only individually, simultaneous operations are not allowed. This configuration works with three different modes: only with Alex source, only with Nd:YAG source or in the BlendX mode. With the BlendX mode, an initial pulse with Alexandrite source is followed automatically, without overlapping in time, by another pulse of the Nd:YAG source.
This device is intended for medical use only.
V. Indications for Use
The Nd:YAG 1064 Laser is intended for:
- । Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
- -Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
- -Coagulation and hemostasis of soft tissue.
- -Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags,
6
Image /page/6/Picture/1 description: The image shows the logo for "bios A LUMENIS COMPANY". The word "bios" is written in a sans-serif font, with the letters in lowercase and connected. Below the word "bios" is the text "A LUMENIS COMPANY" in a smaller, sans-serif font. The logo is simple and modern, with a clean design.
keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
- -Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- -Treatment of wrinkles.
- -Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).
The Alexandrite 755 laser is intended for:
- -Temporary hair reduction.
- -Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I – VI, including tanned skin.
- -Treatment of benign pigmented lesions.
- Treatment of wrinkles. -
- -Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Comparison of technological characteristics with the predicate and reference devices VI.
The Splendor X device and its predicate device are based on the same technological principle of two solid-state laser emission (Alexandrite and Nd:YAG). The two laser sources wavelength are intended for the same indications for use.
The subject and predicate devices are based on the following same technological elements, such as, same laser sources, wavelengths, delivery system, power supply, cooling system, optic, user interfaces and display screen. Both the subject device and the predicate share operating principles, such as energy, repetition rate, available spot sizes.
The subject device includes an energy check port that was not included in the predicate device. For this reason, a reference device is selected to support the full equivalence comparison. Any other difference does not raise any new or modified safety and/or effectiveness questions due to the similarities to the predicate device.
| Item for comparison | Splendor X
(Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Subject device | Family of Square Epil
(Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Predicate device K161632 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General/Regulatory Information | | |
| Manufacturer | Bios S.r.l. | Bios S.r.l. |
| 510(k) number | Subject of this submission | K161632 |
| | Splendor X | Family of Square Epil |
| Item for comparison | (Alex, Alex², Nd:YAG, Alex+Nd:YAG)
Subject device | (Alex, Alex², Nd:YAG, Alex+Nd:YAG)
Predicate device K161632 |
| Device Classification
Name | Powered laser surgical instrument | Powered laser surgical instrument |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product Code | GEX | GEX |
| Regulation Medical
Specialty | General & Plastic Surgery | General & Plastic Surgery |
| Regulation Name | Laser surgical instrument for use in
general and plastic surgery and in
dermatology. | Laser surgical instrument for use in
general and plastic surgery and in
dermatology. |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| Classification | Class II | Class II |
| Indications for Use | The Nd:YAG 1064 Laser is intended for:
• Removal of unwanted hair, for stable
long term or permanent hair reduction
and for treatment of Pseudofolliculitis
barbae (PFB). 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 lasers are
indicated on all skin types, such as
Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of
benign pigmented and vascular lesions
such as but not limited to port-wine
stains, hemangioma, warts,
telangiectasia, rosacea, venus lake, leg
veins and spider veins.
• Coagulation and hemostasis of soft
tissue.
• Treatment of benign pigmented lesions
such as, but not limited to, lentigos (age
spots), solar lentigos (sun spots), cafè au
lait macules, seborrheic keratosis, nevi,
chloasma, verrucae, skin tags, keratosis,
tattoos (significant reduction in the
intensity of black and/or blue-black
tattoos) and plaques. The laser is
indicated for benign pigmented lesions
to reduce lesion size, for patients with
benign lesions that would potentially
benefit from aggressive treatment, and
for patients with benign lesions that
have not responded to other laser
treatments.
• Reduction of red pigmentation in
hypertrophic and keloid scars where
vascularity is an integral part of the scar. | The Nd:YAG 1064 Laser is intended for:
• Removal of unwanted hair, for stable
long term or permanent hair reduction
and for treatment of Pseudofolliculitis
barbae (PFB). 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 lasers are
indicated on all skin types Fitzpatrick I-VI
including tanned skin.
• Photocoagulation and hemostasis of
benign pigmented and vascular lesions
such as but not limited to port wine
stains, hemangioma, warts,
telangiectasia, rosacea, venus lake, leg
veins and spider veins.
• Coagulation and hemostasis of soft
tissue.
• Treatment of benign pigmented lesions
such as, but not limited to, lentigos (age
spots), solar lentigos (sun spots), cafè au
lait macules, seborrheic keratosis, nevi,
chloasma, verrucae, skin tags, keratosis,
tattoos (significant reduction in the
intensity of black and/or blue-black
tattoos) and plaques. The laser is
indicated for benign pigmented lesions
to reduce lesion size, for patients with
benign lesions that would potentially
benefit from aggressive treatment, and
for patients with benign lesions that
have not responded to other laser
treatments.
• Reduction of red pigmentation in
hypertrophic and keloid scars where
vascularity is an integral part of the scar. |
| | Splendor X
(Alex, Alex², Nd:YAG, Alex+Nd:YAG)
Subject device | Family of Square Epil
(Alex, Alex², Nd:YAG, Alex+Nd:YAG)
Predicate device K161632 |
| Item for comparison | Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) The Alexandrite 755 laser is intended for: Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I – VI, including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) The Alexandrite 755 laser is intended for: Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types (Fitzpatrick I – VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). |
| Laser Class | 4 | 4 |
| Laser source | Alexandrite (Alex)
Nd:YAG | Alexandrite (Alex)
Nd:YAG |
| Spot size | Square: 2mm, 3mm, 5 mm, 10mm,
14mm, 18mm, 20mm, 24mm,
27mm;
Round: 2mm, 3mm, 5 mm, 10mm,
14mm, 18mm, 20mm, 24mm,
26mm, 30 mm | Square: 2mm, 3mm, 5 mm, 10mm,
14mm, 18mm, 20mm, 24mm,
27mm;
Round: 2mm, 3mm, 5 mm, 10mm,
14mm, 18mm, 20mm, 24mm,
26mm, 30 mm |
Table 1: Predicate Device SE comparison
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Image /page/7/Picture/1 description: The image shows the logo for "bios, a Lumenis company". The word "bios" is written in a sans-serif font, with the letters in a dark blue color. Below the word "bios" is the text "A LUMENIS COMPANY" in a smaller, sans-serif font, also in dark blue. The logo is simple and modern, with a focus on the company name.
8
Image /page/8/Picture/1 description: The image shows the logo for "bios, a Lumenis company". The word "bios" is written in a simple, sans-serif font, with the letters connected in a flowing, cursive-like style. The color of the text is a dark blue. Below the word "bios", in a smaller font size, is the text "A LUMENIS COMPANY", also in dark blue.
9
Image /page/9/Picture/1 description: The image shows the logo for "bios A LUMENIS COMPANY". The word "bios" is written in a lowercase sans-serif font, with the letters "b", "i", "o", and "s" connected. The color of the word is a dark blue. Below the word "bios" is the text "A LUMENIS COMPANY" in a smaller, sans-serif font, also in dark blue.
The subject device has the same technical features of the predicate excepting for the energy check port that was not introduced at the time of the predicate submission. This difference is supported by the equivalence with the reference device.
The Splendor X and the GentleMax Pro Plus share the same regulatory classification, similar indications for use and technological characteristics included the handpiece power port access.
Table 2: Reference Device SE comparison
| Item for comparison | Splendor X
(Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Subject device | GentleMax Pro Plus
Reference device K201111 | Equivalence
and/or difference |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Indications for Use | The Nd:Yag 1064 Laser is intended for:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin. Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. | 1064nm:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue. | Same |
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Image /page/10/Picture/1 description: The image shows the logo for "bios A LUMENIS COMPANY". The word "bios" is written in a lowercase sans-serif font, with the letters in a dark blue color. Below the word "bios" is the text "A LUMENIS COMPANY" written in a smaller sans-serif font, also in dark blue. The logo is simple and modern, with a focus on the company name.
| Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. | Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. |
|---|---|
| The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. | The laser is 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. |
| Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. | Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. |
| Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) | Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.) |
| The Alexandrite 755 laser is intended for: Temporary hair reduction. | 755nm: Temporary hair reduction. |
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Image /page/11/Picture/1 description: The image shows the logo for "bios A LUMENIS COMPANY". The word "bios" is written in a lowercase, sans-serif font, with the dot over the "i" replaced by a curved line. Below "bios", in smaller letters, is the text "A LUMENIS COMPANY", also in a sans-serif font. The logo is in a dark blue color.
| Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I – VI, including tanned skin. | Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin. | ||
|---|---|---|---|
| Treatment of benign pigmented lesions. | Treatment of benign pigmented lesions. | ||
| Treatment of wrinkles. | Treatment of wrinkles. | ||
| Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | ||
| Manufacturer | Bios S.r.l. | Candela Corp. | NA |
| Device Classification Name | Powered laser surgical instrument | Powered laser surgical instrument | Same |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product Code | GEX | GEX | Same |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology. | Laser surgical instrument for use in general and plastic surgery and in dermatology. | Same |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery | Same |
| Classification | Class II | Class II | Same |
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Image /page/12/Picture/1 description: The image shows the logo for "bios, A LUMENIS COMPANY". The word "bios" is written in a sans-serif font with a lowercase "b" and "i", and an uppercase "O" and "S". The letters are connected. Below the word "bios" is the text "A LUMENIS COMPANY" in a smaller, sans-serif font.
| Similar. | |||
|---|---|---|---|
| Energy check port | Yes | Yes ("Calibration Port") | Both the subject |
| device and the | |||
| reference device | |||
| are equipped with | |||
| a handpiece | |||
| housing, integrated | |||
| in the chassis, that | |||
| allows the user to | |||
| check the emitted | |||
| energy. |
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Image /page/13/Picture/1 description: The image shows the word "bios" in a sans-serif font, with the letters in a dark blue color. Below the word "bios" is the phrase "A LUMENIS COMPANY" in a smaller, sans-serif font, also in a dark color. The logo appears to be for a company called "bios" that is associated with Lumenis.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation of the Splendor X device was conducted, and documentation was provided in accordance with the FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and the recognized consensus standard ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
The Splendor X device is categorized as follow:
- Category: "surface device"
- Contact: "intact skin"
- Contact duration: "limited" (≤24h).
The biocompatibility testing included the following endpoints:
- . Cytotoxicity
- Sensitization
- Irritation
Electrical safety and electromagnetic compatibility (EMC)
The Splendor X has been tested and it is compliant with the recognized consensus standards:
- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- . 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;
- . IEC 60601-2-22: 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: Safety of laser products - Part 1: Equipment classification and requirements
Software Verification and Validation Testing and Cybersecurity
Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions". The software for this device was verified according to IEC 62304.
Cybersecurity information has been provided according to FDA's Guidance for Industry and FDA Staff "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
The results of the Verification and Validation performed with Splendor X met the applicable requirements.
Usability Testing
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Image /page/14/Picture/1 description: The image shows the logo for "bios, A LUMENIS COMPANY". The word "bios" is written in a rounded, sans-serif font, with the letters in a dark blue color. Below "bios", in a smaller font size, is the text "A LUMENIS COMPANY", also in dark blue. The logo is simple and modern, with a focus on the company name.
Usability of the Splendor X have been tested and it is compliant with the recognized consensus standards:
- EN IEC 60601-1-6: Medical electrical equipment — Part 1-6: General requirements for the basic safety and essential performance — Collateral standard: Usability;
- IEC 62366-1: Medical devices - Application of usability engineering to medical devices
Animal and Clinical Study
Animal and clinical studies were not necessary to demonstrate that the performances are equivalent to the predicate devices.
VIII. Conclusion
Based on the comparison analysis with the predicate device (K161632), the non-clinical data that support the safety and effectiveness of the Splendor X and the hardware and software verification and validation that demonstrate that the device performs as intended in the specified use conditions, it can be concluded that Splendor X performs comparably to the predicate device that is currently marketed for the same intended use and to the reference device, when referred the technological difference.