(31 days)
The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength :
- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
The reepot Nd;Y AG laser system is comprised of the following major components:
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- Laser system console
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- LCD control panel
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- VSLS handpieces (included camera and LCD display)
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- Footswitch.
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- Accessories
This document is a 510(k) premarket notification for a laser surgical instrument, the reepot Nd:YAG laser system. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data for acceptance criteria against a specific medical condition. Therefore, the detailed information requested regarding clinical effectiveness studies, such as the use of test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not available in this document.
The document primarily addresses safety and technical equivalence, rather than clinical performance acceptance criteria.
However, I can extract the relevant information that is available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative "acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it demonstrates technical performance and safety compliance by comparing its specifications to a predicate device and adhering to recognized standards.
| Parameter | reepot Nd;YAG laser system (K222555) (Reported Performance - as presented for equivalence) | CuRAS Nd;YAG laser system (K173038) (Predicate) |
|---|---|---|
| Product Code & Regulation No. | GEX, 21 CFR 878.4810 | GEX, 21 CFR 878.4810 |
| Laser Medium | Nd:YAG | Nd:YAG |
| Laser wavelength | 532nm | 1064nm/532nm |
| Output energy | Max 0.35J @532 nm | Max 1.6J @1064 nm; Max 0.4J @532 nm |
| Pulse width | 5-20ns | 5-20ns |
| Repetition Rate | 1-10Hz | 1-15Hz |
| Spot size | 4mm, 6mm | 2mm-10mm |
| Aiming beam | Diode 635nm 5mW | Diode 635nm 5mW |
| User Interface | LCD touch screen | LCD touch screen |
| Optical guide | Articulated arm | Articulated arm |
| Electrical Requirements | 220-230VAC, 50-60 Hz | 220-230VAC, 50-60 Hz |
| General Indications for Use | Incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. | Incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. |
| 532nm Wavelength Specific Indications | Tattoo removal (light ink), Removal of Epidermal Pigmented Lesions, Removal of Minor Vascular Lesions, etc. | Tattoo removal (light ink), Removal of Epidermal Pigmented Lesions, Removal of Minor Vascular Lesions, etc. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data is presented in this 510(k) submission. The submission states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set and thus no ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set is mentioned.
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 a laser surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical studies were performed for this submission, no ground truth data from such studies is provided. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device, and that it adheres to relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
8. The sample size for the training set:
- Not Applicable. This submission is for a physical medical device (laser system), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/ML model is involved.
§ 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.