(90 days)
- CO2 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.
The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.
- Fractional mode includes three modes: normal, random and midsplit;
- Impulse mode includes three modes: single, continuous and impulse.
The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.
The provided FDA 510(k) clearance letter describes a "Fractional CO2 Laser Machine" (K250782) and its substantial equivalence to a predicate device, the "Ilooda Fraxis CO2 Laser" (K172096).
However, the document primarily focuses on demonstrating substantial equivalence through non-clinical performance and safety comparisons rather than detailing specific acceptance criteria for a study that proves the device meets those criteria, particularly in the context of device performance outcomes for intended use. The clearance is based on the device being as safe and effective as its predicate through these comparisons and compliance with relevant standards.
Therefore, many of the requested sections regarding the study that proves acceptance criteria (especially clinical study details, ground truth, expert involvement, and reader studies) cannot be extracted from this document as such studies are explicitly stated to be not included.
Here's an analysis of what can and cannot be extracted:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The "reported device performance" is presented through direct comparison with the predicate.
Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Parameter | Acceptance Criteria (Implicitly based on Predicate & Standards) | Reported Device Performance (Proposed Device) | Comparison / Remark |
|---|---|---|---|
| General | |||
| Device Name | Equivalent to predicate (Ilooda Fraxis CO2 Laser) | Fractional CO2 Laser Machine | Equivalent |
| Classification Regulation | 21 CFR 878.4810 (SAME as Predicate) | 21 CFR 878.4810 | SAME |
| Classification Panel | General & Plastic Surgery (SAME as Predicate) | General & Plastic Surgery | SAME |
| Class | II (SAME as Predicate) | II | SAME |
| Product Code | GEX, ONG (SAME as Predicate) | GEX, ONG | SAME |
| Common Name | Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output (SAME as Predicate) | Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output | SAME |
| Indications for Use | Ablative skin resurfacing (fractional mode); incision, excision, ablation, vaporization, coagulation of body soft tissues (non-fractional mode) (SAME as Predicate) | Same as predicate (listed in document) | SAME |
| Prescription Use | Prescription use (SAME as Predicate) | Prescription use | SAME |
| Performance (Technical Specifications) | |||
| Laser Type | CO2 (SAME as Predicate) | CO2 | SAME |
| Laser Wavelength | 10.6μm (SAME as Predicate) | 10.6μm | SAME |
| Output power | 30W (SAME as Predicate) | 30W | SAME |
| Pulse Duration | 20-5,000μs (Predicate range) | 100-5,000μs | SAME (within range) |
| Fractional Pulse energy | Max 150mJ (SAME as Predicate) | Max 150mJ | SAME |
| Repetition rate | 1,000Hz (SAME as Predicate) | 1,000Hz | SAME |
| Scan area | 20x20mm (SAME as Predicate) | 20x20mm | SAME |
| Spot size | 100-200μm (Fractional), Max 1.3mm (Non-fractional) (SAME as Predicate) | 100-200μm (Fractional), Max 1.3mm (Non-fractional) | SAME |
| Number of microbeams per surface area (fractional) | Max 289 spot/cm2 (SAME as Predicate) | Max 289 spot/cm2 | SAME |
| Energy per microbeam (fractional) | 150mJ (SAME as Predicate) | 150mJ | SAME |
| Total power per surfaced area (fractional) | Max 30W (SAME as Predicate) | Max 30W | SAME |
| Treatment Time | 10-15 min (SAME as Predicate) | 10-15 min | SAME |
| Pulse rate (non-fractional) | 1Hz – 1,000Hz (SAME as Predicate) | 1Hz – 1,000Hz | SAME |
| Pulse width (non-fractional) | 20μs –5000μs (Predicate range) | 100μs –5000μs | SAME (within range) |
| Operational mode | Fractional mode, Normal mode (CW, Pulse, Single Pulse) (Predicate) | Fractional mode, Impulse mode (single/continuous/impulse) | SAME |
| Aiming beam | Diode laser (Red), Max 4mW (SAME as Predicate) | Diode laser (Red), Max 4mW | SAME |
| Cooling | Air cooling (SAME as Predicate) | Air cooling | SAME |
| User Interface | LCD touch screen (SAME as Predicate) | LCD touch screen | SAME |
| Optical guide | Articulated arm (SAME as Predicate) | Articulate system | SAME |
| Electrical Requirements | 100-240VAC, 50-60 Hz, 6.3 A (Predicate) | 100-120V~, 50-60Hz | Analysis |
| Energy flux per μ beams | (4.810^5~1.910^6) mJ/cm2 (SAME as Predicate) | (4.810^5~1.910^6) mJ/cm2 | SAME |
| Power flux per μbeam | (9.510^7~3.810^8)mW/cm2 (SAME as Predicate) | (9.510^7~3.810^8)mW/cm2 | SAME |
| Inter-beam spacing | Determined by micro beam diameter & density of 289 spot/cm2 (Predicate) | 0.6mm-2.6mm (Derived) | Analysis |
| Safety | |||
| Electrical Safety | Comply with IEC 60601-1 (SAME as Predicate) | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 (SAME as Predicate) | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 (SAME as Predicate) | Comply with IEC 60601-2-22, IEC 60825-1 | SAME |
| Biocompatibility: Cytotoxicity | No Cytotoxicity (SAME as Predicate & ISO 10993-5) | No Cytotoxicity | SAME |
| Biocompatibility: Irritation | No evidence of irritation (SAME as Predicate & ISO 10993-23) | No evidence of irritation | SAME |
| Biocompatibility: Sensitization | No evidence of sensitization (SAME as Predicate & ISO 10993-10) | No evidence of sensitization | SAME |
Study Information (Based on the provided document)
As per Section 10, "No clinical study is included in this submission," and Section 9 "Non Clinical Test Conclusion," the device relies on non-clinical testing and substantial equivalence to a predicate. Therefore, the following sections cannot be fully addressed with the provided text for a clinical study proving acceptance criteria.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable (N/A) for clinical outcomes given no clinical study was performed. For non-clinical tests, specific sample sizes (e.g., number of units tested for electrical safety, number of samples for biocompatibility) are not detailed in this summary, but are typically defined by the referenced standards.
- Data Provenance: N/A for clinical data. For non-clinical compliance testing, the provenance is from manufacturer-conducted tests or accredited labs demonstrating adherence to international standards (e.g., IEC, ISO).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical study for which ground truth would be established by experts is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical study with adjudicated outcomes is described.
-
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:
- N/A. Such a study would be relevant for devices involving image interpretation or AI assistance, which this laser device is not described as having.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/algorithm-driven diagnostic device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For non-clinical tests, the "ground truth" is defined by the passing criteria of the referenced international standards (e.g., specific thresholds for electromagnetic compatibility, absence of cytotoxicity).
-
The sample size for the training set:
- N/A. No algorithm or AI component requiring a training set is mentioned.
-
How the ground truth for the training set was established:
- N/A. No algorithm or AI component requiring a training set is mentioned.
§ 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.