(214 days)
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No
The summary describes a laser device with specific physical parameters and indications for use, with no mention of AI or ML capabilities.
No
The device is indicated for treating benign epidermal pigmented lesions and tattoos, which are not conditions typically considered diseases or conditions that require therapeutic intervention for health restoration or improvement. The term "therapeutic device" usually implies a device used to treat a disease, illness, or medical condition to restore health or alleviate symptoms.
No
Explanation: The device is described as a laser for treating benign epidermal pigmented lesions and tattoos, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or diagnose medical conditions.
No
The device description clearly states it is a laser operating at a specific wavelength and includes a delivery system with an articulating arm and handpiece, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description of the Spectrum Epilaser® clearly indicates it is a laser device used for treating conditions (benign epidermal pigmented lesions and tattoos) by targeting chromophores within the body. It is a therapeutic device that interacts directly with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on laboratory tests.
Therefore, the Spectrum Epilaser® is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).
Product codes
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Device Description
The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 usec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.
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
Data from in vitro, in vivo and clinical results found in the open literature were also provided
Key Metrics
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Predicate Device(s)
The Epilaser® was compared to bre-enactment normal mode ruby laser devices of substantially equivalent physical characteristics and indications for use and to post enactment devices with substantially equivalent mechanisms of action and indications for use.
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
K 955612_
9 1996
510(k) Summary
RE: K955612, 510(k) Spectrum Epilaser® Normal Mode Ruby Laser
Date Prepared:
Submitted by:
July 3, 1996
Spectrum Medical Technologies, Inc. (Wholly Owned Subsidiary of Palomar Medical Technologies, Inc., Beverly MA) 45 Hartwell Avenue Lexington, MA 02173 (508)650-4640
Contact:
Proprietary Name:
Erilaserá
Common Name
- laser(光)
Dermatology Laser System
Sanford Lane, President
Predicate Devices: The Epilaser® was compared to bre-enactment normal mode ruby laser devices of substantially equivalent physical characteristics and indications for use and to post enactment devices with substantially equivalent mechanisms of action and indications for use. Data from in vitro, in vivo and clinical results found in the open literature were also provided
Device Description: The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 usec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.
Intended Uses: The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).
The Epilaser® was demonstrated to be substantially equivalent to the predicate devices on the basis of similar mechanisms of action and indications for use.