(28 days)
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).
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.
The provided text is a 510(k) premarket notification for a medical device called Splendor X. This document asserts substantial equivalence to a predicate device and does not describe a study that establishes new acceptance criteria or proves the device meets them with clinical performance data. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed device (the predicate).
Therefore, specific information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and training set ground truth establishment is not available in this document because it is largely focused on demonstrating substantial equivalence through technical comparisons and compliance with recognized standards, rather than new clinical trials with performance endpoints.
The document states: "Animal and clinical studies were not necessary to demonstrate that the performances are equivalent to the predicate devices." This confirms that a novel study to prove the device meets acceptance criteria as typically understood for new performance claims was not conducted or presented in this submission.
However, I can extract the comparison data provided for substantial equivalence, which serves as an "acceptance" of comparable features and performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here implicitly refer to the substantial equivalence to the predicate device, "Family of Square Epil (Alex, Alex2, Nd:YAG, Alex+Nd:YAG), K161632," and reference device "GentleMax Pro Plus, K201111." The "reported device performance" is a comparison of technical specifications and indications for use.
| Item for Comparison | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (Splendor X) |
|---|---|---|
| General/Regulatory Information | ||
| Manufacturer | Bios S.r.l. (Predicate) | Bios S.r.l. |
| 510(k) number | K161632 (Predicate) | Subject of this submission (K241407) |
| Trade Name | Family of Square Epil (Predicate) | Splendor X |
| 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 (Nd:YAG 1064 Laser) | ||
| Hair Removal/Reduction | Removal of unwanted hair, stable long term or permanent hair reduction, PFB treatment (Fitzpatrick I-VI, tanned skin). Permanent reduction defined at 6, 9, 12 months. | Same |
| Pigmented/Vascular Lesions | Photocoagulation/hemostasis of benign pigmented and vascular lesions (e.g., port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins). | Same |
| Soft Tissue | Coagulation and hemostasis of soft tissue. | Same |
| Benign Pigmented Lesions | Treatment of benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos). Indicated for size reduction, aggressive treatment, and non-responsive lesions. | Same |
| Scar Reduction | Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is integral. | Same |
| Wrinkles | Treatment of wrinkles. | Same |
| Onychomycosis | Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, T. rubrum, T. mentagrophytes, C. Albicans). | Same |
| Indications for Use (Alexandrite 755 Laser) | ||
| Hair Reduction | Temporary hair reduction. Stable long-term or permanent hair reduction (Fitzpatrick I-VI, tanned skin). Permanent reduction defined at 6, 9, 12 months. | Same (minor wording difference on permanent hair reduction definition, but intent is same) |
| Benign Pigmented Lesions | Treatment of benign pigmented lesions. | Same |
| Wrinkles | Treatment of wrinkles. | Same |
| Vascular Lesions | Photocoagulation of dermatological benign vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias). | Same (minor wording difference, "The photocoagulation" vs "Photocoagulation of", but intent is same) |
| Technical Characteristics | ||
| Laser Class | 4 | 4 |
| Laser source | Alexandrite (Alex), Nd:YAG | Alexandrite (Alex), Nd:YAG |
| Spot size | Square: 2, 3, 5, 10, 14, 18, 20, 24, 27mm; Round: 2, 3, 5, 10, 14, 18, 20, 24, 26, 30mm | Square: 2, 3, 5, 10, 14, 18, 20, 24, 27mm; Round: 2, 3, 5, 10, 14, 18, 20, 24, 26, 30 mm |
| Energy check port | No (Predicate) / Yes ("Calibration Port", Reference) | Yes (Subject device includes an energy check port, similar to the reference device, but an addition not present in the original predicate) |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable. The submission states, "Animal and clinical studies were not necessary to demonstrate that the performances are equivalent to the predicate devices." The substantial equivalence is based on technical comparisons and compliance with relevant standards.
- Data provenance: Not applicable for a clinical test set. The data provenance discussed relates to technical documentation and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No clinical test set with expert-established ground truth was used for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI/CADe device. It is a laser surgical instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical test set with ground truth was used. The submission relies on technical specifications and regulatory compliance.
8. The sample size for the training set:
- Not applicable. No software requiring a training set for clinical performance claims was described.
9. How the ground truth for the training set was established:
- Not applicable. No training set was described for clinical performance claims.
§ 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.