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The SPECTRA Laser System is 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 Café-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
-Treatment of melasma.

The SPECTRA Laser System produces a pulsed beam of coherent near infrared 11064 nm) and visible (532nm) light. This beam is directed to the treatment zone (100 Film) and risulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm.

When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles.

By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The provided 510(k) Summary for the Lutronic Corporation Spectra Laser System (K113588) does not include any performance data or a study demonstrating the device meets acceptance criteria.

Section 7, titled "Performance Data," explicitly states: "None presented."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the document.

The submission focuses solely on demonstrating substantial equivalence to predicate devices based on similarities in indications for use and technological characteristics.

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The SPECTRA Laser System is 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 Café-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 SPECTRA Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The provided 510(k) summary for the Lutronic Corporation SPECTRA Laser System (K103455) does not include any performance data or a study to demonstrate that the device meets acceptance criteria.

The "Performance Data" section explicitly states: "None presented."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided document.

The document primarily focuses on:

• General Information: Submitter, contact, preparation date, device name, classification.
• Predicate Devices: Identifying an earlier version of the same product and a competitor's product for substantial equivalence claim.
• Device Description: Explaining how the laser system works and its technical specifications (wavelengths, handpieces).
• Indications for Use: Listing the medical conditions and procedures for which the device is intended.

The FDA's decision to clear this device (as indicated by the letter from the Public Health Service) is based on a determination of substantial equivalence to legally marketed predicate devices, rather than on new clinical performance data for this specific iteration. Substantial equivalence generally implies that the device is as safe and effective as the predicate device without requiring new clinical studies if the technological characteristics are similar and the intended use is the same.

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