(122 days)
The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 640-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction
- · For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980nm wavelength
• The removal of unwanted hair and 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 re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime
· For use on Fitzpatrick skin types (I-V)
The LUVO Medical Technologies, Inc. Lucent : IPL is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 430nm to 980nm. The Lucent : IPL system consists of a system console, electronics and software, cooling system, and handpiece with six filters
The provided text is a 510(k) premarket notification summary for the Lucent : IPL device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are explicitly stated as not applicable or not required in this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance for Lucent : IPL
The device, Lucent : IPL, did not undergo a de novo clinical study with specific acceptance criteria in the typical sense for this 510(k) submission. Instead, its performance and safety are established by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly linked to showing that its technical specifications and indications for use fall within the established range or scope of the predicates, and that any differences do not raise new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance:
Since no specific performance metrics with predefined acceptance criteria from a de novo study are presented, the "acceptance criteria" are the ranges and types of indications provided by the predicate devices. The "reported device performance" is the Lucent : IPL's own specifications.
| Characteristic | Predicate K142860 (Lumenis M22 System) | Predicate K072564 (Alma Harmony XL Multi-Application Platform) | Lucent : IPL (K193072) Reported Performance | Notes on Equivalence |
|---|---|---|---|---|
| Wavelength (nm) | 400-1200nm (Varies by handpiece) | 515-950nm (Varies by handpiece) | 430-980nm (Across 6 filters) | The Lucent : IPL wavelength ranges often overlap or fall within the combined ranges of the predicate devices. |
| Intended Use | Aesthetic & cosmetic applications requiring selective photothermolysis (photocoagulation/coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology. | Same as K142860. | Same as K142860. | Verbally identical. |
| Indications for Use (General) | Benign epidermal/cutaneous lesions, vascular lesions, hair removal, moderate inflammatory acne (Predicate K142860 only). | Benign epidermal/cutaneous lesions, vascular lesions, hair removal, moderate inflammatory acne (Predicate K072564 only). | Benign pigmented epidermal/cutaneous lesions (dyschromia, hyperpigmentation, melasma, ephelides, striae, lentigines) and Benign cutaneous vascular lesions (port wine stains, hemangiomas, facial/truncal telangiectasias, angiomas/spider angiomas, poikiloderma of Civatte). Also includes permanent hair reduction for specific wavelengths. | The Lucent : IPL's indications are a subset of or align with those of the predicate devices. The document highlights the specific conditions addressed by each wavelength of the Lucent : IPL. |
| Pulse Width (msec) | 4-20 (K142860); 10-15 (K072564, specific handpieces); 30-50 (K072564, specific handpieces); ≤30msec/1,3 and 30 sec (K072564, specific handpieces); ≤6msec (K072564, specific handpieces). | Varies by handpiece, examples: 10-15 msec, 30-50 msec, etc. | 3-35 msec | The Lucent : IPL's pulse width range (3-35 msec) overlaps considerably with pulse widths of the predicate devices. |
| Energy Density (Fluence) (J/cm²) | 10-35 J/cm² (K142860); 10-30 J/cm² (K072564, specific handpieces); 1-15 J/cm² / 10-30 J/cm² (K072564, specific handpieces); 10-25 J/cm² (K072564, specific handpieces); 5-25 J/cm² (K072564, specific handpieces); 1-7 J/cm² / 0.5-1.5 J/cm² (K072564, specific handpieces). | Varies by handpiece, examples: 10-30 J/cm², 1-15 J/cm², etc. | 6-40 J/cm² | The Lucent : IPL's energy density range (6-40 J/cm²) encompasses or overlaps with the ranges of the predicate devices. |
| Spot Size (mm) | 15mm x 35mm / 8mm x 15mm (K142860); 3cm² / 6.4 cm² (K072564, specific handpieces). | Varies by handpiece, examples: 3 cm², 6.4 cm². | 15mm x 40mm | The Lucent : IPL's spot size is comparable to and falls within the realm of spot sizes offered by predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. A human clinical study (test set) was explicitly not required for this 510(k) submission, as stated in the document ("Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.").
- Data Provenance: Not applicable, as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.
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 an IPL system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device for treatment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The basis for clearance is substantial equivalence to existing legally marketed predicate devices, meaning that the device's technical specifications and indications for use are similar enough not to raise new safety or effectiveness concerns. The "ground truth" in this context is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" proving the Lucent : IPL meets acceptance criteria is the 510(k) premarket notification review process, which involved:
- Comparison to Predicate Devices: The submission meticulously compares the Lucent : IPL's technical specifications (wavelength, intended use, indications for use, pulse width, energy density, spot size) to two predicate devices:
- Performance Testing (Non-Clinical): The document states that the following performance data was provided:
- ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
- IEC 60601-1-2 Edition 4.0 2014-02 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
- IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
The conclusion, explicitly stated in the document, is: "The Lucent : IPL's intended use, indications for use and technical specifications are substantially equivalent to the Harmony XL Multi-Application Platform and the M22 System." This "substantial equivalence" is the "proof" accepted by the FDA for clearance in this case, rather than a de novo clinical study with specific performance metrics.
§ 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.