Ariz. Admin. Code § 9-7-1438

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-7-1438 - Hair Removal and Other Cosmetic Procedures Using Laser and Intense Pulsed Light

A. In addition to the definitions in A.R.S. § 32-516 and R9-7-102 and R9-7-1402, the following definitions apply in this Section and R9-7-1439 unless otherwise specified:

1. "Prescribing health professional" means a health professional who is authorized by the health professional's regulatory board to order and use a "prescription-only device," as defined in A.R.S. § 32-1901.

2. "Cosmetic procedure" means any of the following:

a. Hair reduction,

b. Skin rejuvenation,

c. Non-ablative skin resurfacing,

d. Spider vein reduction,

e. Skin tightening,

f. Wrinkle reduction,

g. Laser peel,

h. Telangiectasia reduction,

i. Acquired adult hemangioma reduction,

j. Facial erythema reduction,

k. Solar lentigo reduction (age spots),

l. Ephelis reduction (freckles),

m. Acne scar reduction,

n. Photo facial,

o. Tattoo removal,

p. Cellulite reduction, or

q. Another, as approved by the Department after consultation with other health professional boards as defined in A.R.S. § 32-516(F)(3) or 32-3233(D)(1).

B. A person who seeks to perform hair removal or other cosmetic procedures shall apply for registration, under R9-7-1302(F)(7), of any medical laser or IPL device that is a Class II surgical device, certified by the manufacturer as complying with the labeling standards in 21 CFR 801.109, revised June 15, 2016, incorporated by reference, available under R9-7-101, and including no future editions or amendments.

C. An applicant for registration shall submit to the Department:

1. The following information, in a Department-provided format:

a. The name, mailing address, billing address if different from the mailing address, telephone number, and e-mail address of the applicant;

b. Any other names by which the applicant is known;

c. The applicant's type of business organization, including:

i. For a corporation, information as registered with the Arizona Corporation Commission;

ii. For a partnership, the name and address of each partner and percentage of ownership;

iii. For a sole proprietorship, the name of the owner; and

iv. For a governmental entity, documentation showing the applicant is a governmental entity;

d. The type of facility;

e. For the medical laser or IPL device, as applicable:

i. The class and type, and

ii. The name of the manufacturer and model of the medical laser or IPL device;

f. The physical address of the location at which the medical laser or IPL device, as applicable, will be used;

g. The name, title, telephone number, and e-mail address of:

i. A point of contact for the applicant at the location of use, and

ii. A billing point of contact;

h. The name, telephone number, and e-mail address of the prescribing health professional who will be responsible for the use of the medical laser or IPL device in subsection (C)(1)(e), including the prescribing health professional's regulatory board and professional license number;

i. The name, telephone number, and e-mail address of the Laser Safety Officer required in R9-7-1434;

j. Whether the applicant agrees to allow the Department to submit supplemental requests for information under A.R.S. § 41-1075(A);

k. Attestation that the prescribing health professional in subsection (C)(1)(h):

i. Is qualified in accordance with A.R.S. § 32-516 or 32-3233 and subsection (E);

ii. Is responsible for the use of the medical laser or IPL device;

iii. If applicable, will provide indirect supervision of a laser technician certified under 9 A.A.C. 16, Article 7, using the medical laser or IPL device for hair removal; and

iv. If applicable, will provide direct supervision of a laser technician certified under 9 A.A.C. 16, Article 7, using the medical laser or IPL device for a cosmetic procedure other than hair removal;

l. Attestation that the information or documents submitted to the Department are true and correct; and

m. The signature of both the applicant and prescribing health professional and the date signed;

2. Documentation for the individual specified according to subsection (C)(1)(c)(iii) or (g)(i), as applicable, that complies with A.R.S. § 41-1080;

3. Documentation demonstrating that the prescribing health professional in subsection (C)(1)(h) meets the requirements in subsection (E):

4. Documentation demonstrating that the Laser Safety Officer in subsection (C)(1)(i) has completed the training specified according to Appendix D; and

5. The fee in Table 13.1(F)(7).

D. If a registrant is using a medical laser or an IPL device in subsection (A), the registrant shall:

1. Designate a Laser Safety Officer, as required in R9-7-1434, who:

a. May be the registrant or the prescribing health professional; and

b. Has completed the training in Appendix D, as required in R9-7-1421(E);

2. Ensure that policies and procedures are developed, documented, and implemented that:

a. Address the applicable requirements in R9-7-1403, R9-7-1421, R9-7-1427, R9-7-1429, R9-7-1433; R9-7-1434, R9-7-1435, and R9-7-1436;

b. Include procedures to ensure that the prescribing health professional purchases or orders the medical laser or IPL device;

c. If applicable, cover situations in which the prescribing health professional is not present in the facility, according to subsection (D)(8); and

d. Cover the knowledge, skills, and experience of individuals authorized to use the medical laser or IPL device;

3. Ensure that the prescribing health professional:

a. Has established a written protocol for the application of radiation to a patient for each cosmetic procedure that may be conducted using the medical laser or IPL device, including follow-up instructions for the patient;

b. Reviews and, as necessary revises, the written protocols in subsection (D)(3)(a) at least annually; and

c. Documents the review in subsection (D)(3)(b) with a signature and date of signature;

4. Ensure that the registrant has a written order from the prescribing health professional before the application of radiation to a patient;

5. Ensure that the medical laser or IPL device is only used by:

a. A health professional described in A.R.S. §§ 32-516(F)(3) and 32-3233(D)(1) who meets the requirements in subsection (E);

b. A laser technician, certified under 9 A.A.C. 16, Article 7, for the cosmetic procedure to be performed, who:

i. When performing a hair removal procedure, is working under the indirect supervision of a prescribing health professional described in A.R.S. §§ 32-516(C)(1) and 32-3233(D) and (H)(1); and

ii. When performing a cosmetic procedure other than hair removal, is working under the direct supervision of a prescribing health professional described in A.R.S. §§ 32-516(C)(1) and 32-3233(D) and (H)(1); or

c. An individual who has a provisional certificate for course completion issued according to R9-7-1439(E)(3) and:

i. Is receiving hands-on training under the supervision of an individual qualified according to R9-7-1439(F)(2); and

ii. If applicable, when a prescribing health professional is providing indirect supervision to a supervising laser technician in R9-7-1439(F)(2)(b);

6. Ensure that a laser technician follows the applicable written protocol established by the prescribing health professional according to subsection (D)(3)(a) when applying radiation to a patient using the medical laser or IPL device;

7. Ensure that, at least every six months, the prescribing health professional:

a. Observes each laser technician, while the laser technician is performing a hair removal procedure, for adherence to the applicable written protocol in subsection (D)(3)(a); and

b. Documents the observation and the assessment in subsection (D)(7)(a);

8. If the registrant is authorized by the Department to conduct hair removal procedures or other cosmetic procedures without a prescribing health professional being present in the facility:

a. Establish a method for emergency medical care of a patient; and

b. Assume legal liability for the services rendered in the facility by:

i. An indirectly-supervised certified laser technician performing hair removal procedures, or

ii. A health professional performing any cosmetic procedure;

9. Ensure that a laser technician using the medical laser or IPL device displays a valid original certificate, as issued by the Department under A.A.C. R9-16-703, R9-16-704, or R9-16-705, in a location that is viewable by the public;

10. Ensure that labels and signs are used, according to the applicable requirements in R9-7-1427 and R9-7-1429; and

11. Maintain on the premises of the facility:

a. The policies and procedures in subsection (D)(2),

b. The written protocols in subsection (D)(3)(a),

c. Documentation of the review of the written protocols in subsection (D)(3)(b) for at least three years after the date of the review,

d. Documentation of the observation and assessment in subsection (D)(7)(b) for at least three years after the date of the assessment,

e. Documentation of the radiation safety training required in subsection (F) for at least three years after the last date of employment, and

f. Documentation of the training required in subsection (D)(1)(b) for as long as the individual is acting as a Laser Safety Officer.

E. A registrant shall verify that a health professional is qualified to perform a cosmetic procedure using a medical laser or IPL device by obtaining documentation that the health professional:

1. Meets the requirements in A.R.S. §§ 32-516(F)(3) and 32-3233(D)(1); and

2. Has:

a. A certificate of completion of 24 hours of didactic training issued to the health professional by a training program according to Appendix C; or

b. Has been in practice since before October 1, 2010 and has at least 24 hours of training on the subjects in Appendix C.

F. A registrant shall:

1. Provide radiation safety training to all individuals involved with performing cosmetic procedures under subsection (D), consistent with the individual's knowledge, skills, and duties; and

2. Document the radiation safety training, including the date of the training, topics covered, name and qualifications of the individual providing the training, and names of individuals receiving the training.

G. A registrant shall ensure that:

1. A medical laser or IPL device is secured so that the medical laser or IPL device cannot be removed from the facility, and

2. The on/off switch is turned to the "off" position with the key removed when a laser technician or a health professional is not present in the room where the medical laser or IPL device is located.

Ariz. Admin. Code § R9-7-1438

New Section R9-7-1438 recodified from R12-1-1438at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 30 A.A.R. 164, effective 1/4/2024.