Rule 4731-18-01 | Definitions.
As used in this chapter of the Administrative Code:
(A) "Light based medical device " means any device that can be made to produce or amplify electromagnetic radiation at wavelengths equal to or greater than one hundred eighty nm but less than or equal to 1.0 X 10 6nm [ten to the sixth power] and that is manufactured, designed, intended or promoted for irradiation of any part of the human body for the purpose of affecting the structure or function of the body.
(B) "Phototherapy" means the following:
(1) For paragraph (A) of rule 4731-18-04 of the Administrative Code, phototherapy means the application of light for the treatment of hyperbilirubinemia in neonates.
(2) For paragraphs (B) and (C) of rule 4731-18-04 of the Administrative Code, phototherapy means the application of ultraviolet light for the treatment of psoriasis and similar skin diseases. This application can occur with any device cleared or approved by the United States food and drug administration for the indicated use that can be made to produce irradiation with broadband ultraviolet B (290-320nm), narrowband ultraviolet B (311-313 nm), excimer light based (308nm), ultraviolet A1 (340-400nm), or UVA (320-400nm) plus oral psoralen called PUVA.
(C) "Photodynamic therapy" means light therapy involving the activation of a photosensitizer by visible light in the presence of oxygen, resulting in the creation of reactive oxygen species, which selectively destroy the target tissue.
(D) "Ablative dermatologic procedure" means a dermatologic procedure that is expected to excise, burn, or vaporize the skin below the dermo-epidermal junction.
(E) "Non-ablative dermatologic procedure" means a dermatologic procedure that is not expected or intended to excise, burn, or vaporize the epidermal surface of the skin.
(F) "Physician" means a person authorized to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery under Chapter 4731. of the Revised Code and acting within the scope of their practice.
(G) "Delegation" means the assignment of the performance of a service to a person who is not a physician.
(H) "On-site supervision" means the physical presence of the supervising physician is required in the same location (i.e., the physician's office suite) as the delegate of the light based medical device but does not require the physician's presence in the same room.
(I) "Direct physical oversight" means the physical presence of the supervising physician is required in the same room to directly observe the delegate of the light based medical device.
(J) "Vascular laser" means light-based medical devices including lasers and intense pulsed light apparatuses whose primary cutaneous target structures are telangiectasia, venulectasia, and superficial cutaneous vascular structures. In general, these lasers have wavelengths that correspond to the hemoglobin absorption spectrum.
Last updated May 1, 2023 at 8:41 AM
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