(86 days)
532nm: The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
755 nm: The ORION is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm: The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins and poikiloderma of civate; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as,but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. It is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.
The provided document is a 510(k) summary for the ORION Medical Laser System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness. Therefore, the document does not contain information about the acceptance criteria or a dedicated study designed to prove the device meets specific acceptance criteria in the manner of a traditional clinical trial for a novel device.
Instead, the "proof" the device meets the acceptance criteria (which are essentially equivalence to predicate devices) primarily comes from engineering and performance testing against recognized standards, and a comparison of technical specifications and intended uses with predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence, "acceptance criteria" are not explicitly stated in terms of clinical performance metrics that the device must achieve. Instead, the "acceptance criteria" are implicitly that the device's technical specifications and intended uses fall within the established parameters of the predicate devices and that the device meets relevant safety and electrical standards. The "reported device performance" is a demonstration of compliance with these standards and a comparison of specifications.
| Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ORION) |
|---|---|---|
| General Safety and Performance | Compliance with relevant medical electrical equipment standards (e.g., IEC 60601 series, IEC 62366, IEC 60825-1). | Tested against: |
- IEC 60601-1 (general requirements for basic safety and essential performance)
- IEC 60601-1-6 (usability)
- IEC 62366-1 (application of usability engineering)
- IEC 60601-2-22 (particular requirements for surgical/cosmetic/therapeutic/diagnostic laser equipment)
- IEC 60601-1-2 (electromagnetic compatibility)
- IEC 60825-1 (safety of laser products - equipment classification/requirements)
Conclusion: "All the test results support substantial equivalence to the predicate devices." (Page 6) |
| Indications for Use (532nm) | Coagulation and hemostasis of vascular and cutaneous lesions in dermatology (e.g., angiomas, telangiectasia, benign pigmented lesions like nevi, lentigines, tattoos/red & green ink, verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment for hemostasis, color lightening, blanching, flattening, reduction of lesion size), similar to Altus Medical Modified CoolGlide Aesthetic Lasers (K014040). | Matched Indication: Coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). (Page 5 & 6-7 Comparison Table) |
| Indications for Use (755nm) | Stable long-term/permanent hair reduction for all skin types (Fitzpatrick I-VI) including tanned skin, measured at 6, 9, 12 months post-treatment. Treatment of vascular lesions, benign pigmented lesions, and wrinkles, similar to Cynosure Apogee Elite Laser (K034030) and CLARITY LPC Laser System (K130199). | Matched Indication: Stable long-term, or permanent hair reduction (defined as long-term, stable reduction in number of hairs regrowing measured at 6, 9, and 12 months after treatment regime) for all skin types (Fitzpatrick I-VI) including tanned skin. Also indicated for treatment of vascular lesions, benign pigmented lesions, and wrinkles. (Page 5 & 7-8 Comparison Table) |
| Indications for Use (1064nm) | Coagulation and hemostasis of benign vascular lesions (e.g., port wine stains, hemangiomas, superficial venous malformations, warts, telangiectasia, rosacea, leg veins, spider veins, poikiloderma of Civatte); treatment of benign cutaneous lesions (e.g., warts, scars, striae, psoriasis); treatment of benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos/significant reduction in black and/or blue/black ink, plaques); treatment of wrinkles (e.g., periocular, perioral); removal of unwanted hair/stable long-term/permanent hair reduction (melanin targeting in hair follicles); treatment of pseudofolliculitis barbae (PFB). Similar to Altus Medical (K014040), Cynosure (K034030), and CLARITY (K130199). | Matched Indication: Coagulation and hemostasis of benign vascular lesions (such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins, spider veins and poikiloderma of civatte); and treatment of benign cutaneous lesions (such as warts, scars, striae and psoriasis); treatment of benign pigmented lesions (such as lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in intensity of black and/or blue/black tattoos) and plaques); treatment of wrinkles (such as periocular and perioral wrinkles). Additionally, for removal of unwanted hair, for stable long term, or permanent hair reduction (melanin targeting in hair follicles), and for treatment of pseudofolliculitis barbae (PFB). (Page 5 & 8-9 Comparison Table) |
| Technical Specifications | Technical specifications for wavelength, energy, pulse duration, and spot size should be equivalent or similar to predicate devices. | The comparison table (pages 6-9) details specifications for ORION (Subject Device) and three predicate devices across parameters like: - Technology: Long Pulse Nd:YAG (matches all predicates)
- Energy (1064nm): 100J (matches all predicates)
- Energy (755nm): 50J (matches Cynosure, similar to CLARITY's 55J)
- Energy (532nm): 10J (matches Altus)
- Frequency: Ranges are similar/within predicate's capabilities.
- Pulse train duration: Ranges are similar.
- Spot size: 2-20mm (within range of predicate devices).
- Wavelength: 1064nm, 755nm, 532nm (combination of wavelengths available in predicate devices).
- Aiming beam: 650nm (matches all predicates).
- Energy source: Nd:YAG, Alexandrite, KTP (matches combinations in predicates).
- Cooling method: Cold air (matches Cynosure and CLARITY, different from Altus's Sapphire cooling but the overall effectiveness for skin protection is implied to be equivalent through the general performance testing). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical performance data and a comparison to predicate devices. There is no information provided on clinical studies involving a "test set" of patient data, nor any details on sample size, data provenance (country, retrospective/prospective). This is typical for a 510(k) where substantial equivalence is demonstrated through engineering and a comparison to previously cleared 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)
Since no clinical studies with a "test set" are described, there is no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical studies with a "test set" are described, there is no information on an adjudication method.
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
The device is a medical laser system, not an AI-powered diagnostic or assistive tool for human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a medical laser system used for treatment, not an algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable and was not conducted or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
- Established standards: Compliance with international and national safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1).
- Predicate device specifications and clearances: The regulatory "ground truth" is that the predicate devices are legally marketed and have established safety and effectiveness. The ORION's specifications and intended uses are compared to these.
There is no mention of clinical "outcomes data," "pathology," or "expert consensus" related to new clinical trials for the ORION device itself.
8. The sample size for the training set
Since this is not an AI/machine learning device requiring a training set, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no training set for an AI/machine learning device, this information is not applicable and not provided.
§ 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.