Ohio Admin. Code 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) "Off-site supervision" means
that the supervising physician shall be continuously available for direct
communication with the cosmetic therapist.
Notes
Promulgated Under: 119.03
Statutory Authority: 4730.07, 4731.05
Rule Amplifies: 4730.07, 4731.05, 4731.33
Prior Effective Dates: 07/31/2021
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