(242 days)
The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Family of Pulsed Diode Array Laser Systems is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Specific indications for each system and handpiece combination are listed in the document and include:
- Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- Treatment of pseudofolliculitis barbae (PFB)
- Hair removal, permanent hair reduction*
- Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
- Treatment of wrinkles
*Permanent hair reduction 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.
The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. The four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system, (2) the needed electronics to control and power the accessories, (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system.
Handpieces can be divided into two categories, depending on the technology applied to the skin during treatment: high speed (HS) Handpieces with vacuum technology (HIT™) or ET, XC and LR Handpieces with cooling technology (ChillTip), available with different sized tips. Some handpieces are universal, supporting different ChillTip sizes within a single handpiece. In addition, these handpieces either deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), depending on the diode array type. The same LightSheer Handpieces are compatible with multiple systems (such as the LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light), in which case they differ only in terms of the mechanical connection to the console.
The provided text describes a 510(k) submission for the Lumenis LightSheer Family of Pulsed Diode Array Laser Systems. The purpose of the submission is to add 1060nm handpieces to the LightSheer Desire and LightSheer Desire Light Systems, which were previously cleared for use with other systems in the LightSheer Family. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the device's indications for use.
Therefore, the specific information requested in the prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. The document primarily details regulatory compliance and safety testing concerning substantial equivalence.
However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim, which can be interpreted as demonstrating the device meets general safety and effectiveness requirements.
Acceptance Criteria and Reported Device Performance (General Safety and Effectiveness)
While explicit "acceptance criteria" in the format of specific clinical metrics are not provided, the document states performance testing was conducted to verify that the modifications did not raise "different questions of safety and effectiveness." The reported performance is that the device conforms to relevant safety and performance standards.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Risk Analysis | Conforms to ISO 14971 |
| Electrical Safety | Conforms to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - requirements and tests) |
| Laser Safety | Conforms to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements) |
| Medical Laser Equipment Safety | Conforms to IEC 60601-2-22 (Medical electrical equipment - part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment) |
| Software Performance | Software verification and validation performed |
Information Not Available in the Document:
- Sample size used for the test set and the data provenance: The document does not describe a clinical "test set" with patient data or its provenance for demonstrating the device's clinical efficacy against specific acceptance criteria.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical testing with expert-established ground truth is not described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not explicitly stated beyond conformance to engineering and safety standards. There is no mention of expert consensus, pathology, or outcomes data for a clinical ground truth.
- The sample size for the training set: Not applicable, as this is a laser and not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Study Described:
The study referenced in the document is a regulatory "performance testing" conducted internally by Lumenis to demonstrate that the modifications (adding 1060nm handpieces) to the LightSheer Desire and LightSheer Desire Light Systems, and other system modifications, do not raise new questions of safety or effectiveness. This testing primarily involved:
- Risk Analysis: Performed according to ISO 14971.
- Electrical and Laser Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
- Software Verification and Validation: Ensured the software functions as intended and meets requirements.
The document asserts that based on these activities, the device is "substantially equivalent" to its legally marketed predicates. This type of submission relies on demonstrating that the new device or modification is as safe and effective as a predicate device, rather than proving a set of specific clinical performance claims with clinical trials against acceptance criteria.
§ 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.