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K Number
K052848
Device Name
SPECTRA HAIR REMOVAL LASER
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2005-12-27

(81 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K032846,K973324,K982940,K001746,K010580,K011747,K020849,K030235
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Spectra Hair Removal Laser is intended for temporary hair removal.

Device Description

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

AI/ML Overview

The provided text states, "Performance Data: None. The specifications and indications for use of the Spectra Hair Removal Laser are substantially equivalent to those claimed in the clearance for the above-listed predicate devices. Thus performance data were not required."

Therefore, based on the input:

  1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for performance data because it claims substantial equivalence to predicate devices.
  2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted for this device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
  4. Adjudication method for the test set: Not applicable. No performance study was conducted.
  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 is a laser device, not an AI diagnostic tool, and no performance study was conducted.
  6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm.
  7. The type of ground truth used: Not applicable. No performance study was conducted.
  8. The sample size for the training set: Not applicable. No performance study was conducted.
  9. How the ground truth for the training set was established: Not applicable. No performance study was conducted.

§ 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.