(143 days)
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No
The description focuses on laser technology and an embedded processor for control, with no mention of AI or ML terms, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The intended uses listed, such as treatment of wrinkles, scars, and pigmented lesions, as well as skin resurfacing, are all therapeutic procedures.
No
The device description and intended use describe procedures for coagulation, treatment, and resurfacing, which are all therapeutic actions. There is no mention of diagnosing conditions.
No
The device description explicitly states it consists of "a set of fiber lasers, controlled by an embedded processor," and uses "scanning and focusing optics," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Fraxel SR Laser System is used for dermatological procedures that involve applying thermal energy directly to the skin (epidermis and upper dermis). It's a therapeutic device that acts on the patient's body, not on a sample taken from the body.
- Intended Use: The intended uses listed are all clinical treatments performed directly on the patient's skin (coagulation of soft tissue, treatment of wrinkles, scars, pigmented lesions, skin resurfacing).
Therefore, based on the provided information, the Fraxel SR Laser System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of surgical scars and acne scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.
Product codes
GEX
Device Description
The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Clinical performance data was used to demonstrate that the Fraxel SR Laser System functioned as clinically intended. The results from clinical investigation allowed for the determination that the Fraxel SR Laser System performs as clinically intended and that no new issues of safety and effectiveness are introduced.
Key Metrics
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Predicate Device(s)
K050841, K033461, K033331, K041242, K043046, K022060
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Kos 3047
:
APPENDIX A 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
A - l
1