(158 days)
The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:
-treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins;
-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);
verrucae, skin tags, seborrheic keratosis;
- reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
- coagulation and hemostasis of soft tissue;
-the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth 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 Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:
Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles
The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:
- Benign vascular lesions such as, but not limited to treatment of:
Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
-Benign cutaneous lesions, such as, but not limited to:
Warts; Scars; Striae; Psoriasis
-Benign pigmented lesions such as, but not limited to:
Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques - Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- The non-ablative treatment of facial wrinkles, such as, but not limited to:
Periocular wrinkles; Perioral wrinkles;
-Laser skin resurfacing procedures for the treatment of:
Acne scars; Wrinkles - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:
- Incision, excision, ablation, vaporization of soft tissue.
- Tattoo removal: Light blue; Yellow; Red; Green
- Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi
-Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi
-Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques
The 2940 nm Er:YAG Laser Module handpiece is indicated for:
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:
A. Acne scars
- Acne scars . . Wrinkles
The 2940 nm Er: Yag Fractional tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
IPL 400-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions including dyschromia,
hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of benign cutaneous lesions including warts, scars and striae.
· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
·Use on all skin types (Fitzpatrick I-VI).
IPL500-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne (acne vulgaris).
· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth 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.
•Use on Fitzpatrick skin types I-V.
IPL 550-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne Vulgans.
· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
- · The treatment of face and body vascular and pigmented lesions.
· The treatment of cutaneous lesions, including scars and striae.
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth 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.
· Use on all skin types (Fitzpatrick I-VI).
IPL 580-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
· The treatment of face and body vascular and pigmented lesions.
· The treatment of cutaneous lesions, including scars and striae.
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth 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.
· Use on all skin types (Fitzpatrick I-VI).
IPL 620-1200 nm handpiece is iodicated for:
· The treatment of tattoos.
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpiementation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait.
· The treatment of cutaneous lesions including warts, scars and striae.
· The treatment of benign cutaneous vascular lesions includiog port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
: The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6. 9, and 12 months after the completion of a treatment regime.
· Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin.
IPL 755-1200 nm handpiece is indicated for:
• The treatment of tattoos.
· The treatment of moderate ioflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of cutaneous lesions iocluding warts, scars and striae.
· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.
· The treatment of pseudofolliculitis barbae (PFB).
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth 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.
·Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform.
This document is a 510(k) summary for the "SUPERBIUM" medical laser system. It compares the device to several predicate devices to demonstrate substantial equivalence, rather than providing a performance study with specific acceptance criteria against a defined ground truth.
Therefore, many of the requested sections about acceptance criteria and study details cannot be fully answered from this document. However, I can extract the relevant information regarding the device's technical characteristics and the comparison to predicate devices, which serves the purpose of demonstrating equivalence.
Here's a summary of the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission showing substantial equivalence to predicate devices, there isn't a table of explicit acceptance criteria for the study's outcome in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by demonstrating that the SUPERBIUM device's technological characteristics and intended uses are "substantially equivalent" to the listed predicate devices. The "reported device performance" is essentially a comparison of these characteristics.
The tables within the document (e.g., "B) Nd:Yag Handpiece Long Pulse", "C) Nd:Yag Handpiece - Short Pulse", etc.) serve as the core of this comparison. For each handpiece, the SUPERBIUM's specifications (Wavelength, Output power, Max energy per pulse, Beam diameter, Fluence, Pulse duration, Emission frequency, and Intended Use) are presented alongside those of the predicate devices.
Example of "Acceptance Criteria" (Implicit for Substantial Equivalence) and "Reported Device Performance" (Comparison to Predicates):
| Characteristic | SUPERBIUM (Reported Performance) | Predicate Device A (e.g., HARMONY XL K072564) | Predicate Device B (e.g., ICON AESTHETIC SYSTEM K103664) | Implied "Acceptance Criteria" for Substantial Equivalence |
|---|---|---|---|---|
| Nd:Yag LP Wavelength | 1064 nm | 1064 nm | 1064 nm | Wavelength must be identical or clinically similar. |
| Nd:Yag LP Output Power | 45W max | 40W max | 50 W | Within comparable range of predicate devices. |
| Nd:Yag LP Max Energy/Pulse | LP: 45J (max) | 40 J | 50 J | Within comparable range of predicate devices. |
| Nd:Yag LP Fluence (6mm spot) | 160 J/cm2 | 30-150 J/cm2 (6mm) | 16/140 J/cm2 (6mm) | Within comparable range of predicate devices. |
| Nd:Yag LP Pulse Duration | 1 - 25 ms | 40-60 ms (6mm) / 8-15ms (2mm) | 10 - 100 ms | Within comparable range of predicate devices. |
| Nd:Yag LP Emission Freq. | 1 Hz (max) | 1 Hz | 0.2 - 2 Hz | Identical or within comparable range. |
| Intended Use (Nd:Yag LP example) | Treatment of vascular lesions, pigmented lesions, tattoos, hair removal, etc. | Similar scope of treatments. | Similar scope of treatments. | Intended uses must be the same or highly similar. |
Note: The document states "Any differences are considered minor and do not raise new issues of the safety and effectiveness of the SUPERBIUM device when compared to the predicate devices." This is the ultimate "acceptance" for a 510(k).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Animal and clinical studies were not necessary to demonstrate that the permormances are comparable to the predicate devices." Instead, the submission relies on direct comparison of technological characteristics. Therefore, there is no test set sample size or clinical data provenance to report. The data provenance for the comparison itself is simply from the regulatory submissions of the predicate devices.
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, as no clinical study with a test set requiring expert ground truth was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication was conducted.
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, as this is a medical laser system for various dermatological and surgical applications, not an AI-powered diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring a specific ground truth was conducted. The ground for the submission is the regulatory information and technical specifications of the predicate devices.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device and not a machine learning model.
§ 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.