(108 days)
The Tri-Beam Nd:YAG Laser System in indicated for: - the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Caff-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.
The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.
Here's a breakdown of the acceptance criteria and the study information for the E-Beam Nd:YAG Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) summary does not provide explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the "acceptance criteria" are implied through the direct comparison of technical specifications to a predicate device, aiming for substantial equivalence. The reported device "performance" is, therefore, the matching of these technical specs to the predicate.
| Feature | Predicate Device (Lutronic Spectra Laser System K113588) | E-Beam Nd:YAG Laser System (Subject Device) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Q-Switch Laser | ||||
| Laser Medium | Nd:YAG | Nd:YAG | Match Predicate | Nd:YAG |
| Wavelengths | 1064nm / 532nm (Option: 585nm, 650nm) | 1064nm / 532nm (Option: 585nm, 650nm) | Match Predicate | Match Predicate |
| Operating Mode | Q-Switched | Q-Switched | Match Predicate | Q-Switched |
| Beam Profile | Top Hat Mode | Top Hat Mode | Match Predicate | Top Hat Mode |
| Pulse Energy (1064nm) | 1200mJ | 1200mJ | Match Predicate | 1200mJ |
| Pulse Energy (532nm) | 400mJ | 400mJ | Match Predicate | 400mJ |
| Pulse Energy (585nm) | 250mJ | 250mJ | Match Predicate | 250mJ |
| Pulse Energy (650nm) | 150mJ | 150mJ | Match Predicate | 150mJ |
| Pulse Width | 5ns - 10ns | 5ns - 10ns | Match Predicate | 5ns - 10ns |
| Spot Size (1064nm) | 3,4,5,6,7,8mm (Optional: 1,2,3,4,6,7,mm) | 2-8mm (Collimated: 6mm) | Comparable or broader range | 2-8mm (Collimated: 6mm) |
| Spot Size (532nm) | N/A (listed as blank in predicate table) | 6.9mm (listed as blank in predicate table) | Within accepted range for application | 6.9mm |
| Spot Size (585nm) | 2mm | 2mm | Match Predicate | 2mm |
| Spot Size (650nm) | 2mm | 2mm | Match Predicate | 2mm |
| Pulse Duration (1064nm) | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz | Match Predicate | Single, 1,2,5,10 Hz |
| Pulse Duration (532nm) | Single, 1,2,4,5 Hz | Single, 1,2,4,5Hz | Match Predicate | Single, 1,2,4,5Hz |
| Pulse Duration (585nm) | Single, 1,2,4,5 Hz | Single, 1,2,4,5 Hz | Match Predicate | Single, 1,2,4,5 Hz |
| Pulse Duration (650nm) | Single, 1 and 2Hz | Single, 1 and 2Hz | Match Predicate | Single, 1 and 2Hz |
| Beam Delivery | Articulated Arm | Articulated Arm | Match Predicate | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW | Match Predicate | Diode 655nm (Red) 1mW |
| Long Pulse Nd:YAG | ||||
| Laser Medium | Nd:YAG | Nd:YAG | Match Predicate | Nd:YAG |
| Wavelengths | 1064nm | 1064nm | Match Predicate | 1064nm |
| Operating Mode | Long Pulse | Long Pulse | Match Predicate | Long Pulse |
| Beam Profile | Top Hat Mode | Top Hat Mode | Match Predicate | Top Hat Mode |
| Pulse Energy | 1500mJ | 1500mJ | Match Predicate | 1500mJ |
| Pulse Width | 300us | 300us | Match Predicate | 300us |
| Spot Size | 3,4,5,6,7,8mm (Optional: 1,2,3,4,6,7,mm) | 2-8mm (Collimated 6mm) | Comparable or broader range | 2-8mm (Collimated 6mm) |
| Pulse Duration | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz | Match Predicate | Single, 1,2,5,10 Hz |
| Optical Deliver | Articulated Arm | Articulated Arm | Match Predicate | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW | Match Predicate | Diode 655nm (Red) 1mW |
2. Sample Size Used for the Test Set and Data Provenance
- The document explicitly states "None" for "Performance Data: Results of Clinical Study".
- Therefore, there is no test set sample size and no data provenance (country of origin, retrospective or prospective) for a clinical study. The submission relies solely on technical comparison for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since no clinical study was performed, there was no ground truth established by experts for a test set.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical study or test set was used.
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 is a laser device, not an AI diagnostic or assistive device that would involve human "readers" or an "effect size of human improvement with AI." The document explicitly states "None" for clinical study results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (laser system), not an algorithm or AI. The concept of "standalone performance" in this context refers to the device's technical specifications and intended functionality, which were evaluated through direct comparison to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the purpose of this 510(k) submission, the "ground truth" for the device's performance is established by its technical specifications directly matching or being functionally equivalent to the technical specifications of the legally marketed predicate device (Lutronic Spectra Laser System K113588). No clinical ground truth (e.g., pathology, outcomes data) based on human subjects was used.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned or implied.
§ 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.