- A. A person shall apply for registration, under R9-7-1302(F)(7), of a medical laser or an intense pulsed light device for performing hair removal or other cosmetic procedures if the medical laser or intense pulsed light device is a FDA-designated Class II medical device, certified by the manufacturer as complying with the labeling standards in 21 CFR 801.109, June 15, 2016, which is incorporated by reference, is available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-D/section-801.109, is on file with the Department, and includes no future editions or amendments.
B. A registrant shall ensure that:
- 1. The use of an intense pulsed light device regulated under this Article for hair removal or other cosmetic procedures complies with applicable requirements and manufacturer’s specifications, and
- 2. The manufacturer’s user manual for the intense pulsed light device is available on-site.
C. If a registrant is using a medical laser or an intense pulsed light device in subsection (A), the registrant shall:
1. Designate a Laser Safety Officer, as required in R9-7-1408(C)(1), who:
- a. May be the registrant or the prescribing health professional; and
- b. Has completed the training in R9-7-1410, as required in R9-7-1408(C)(2);
2. Ensure that policies and procedures are developed, documented, and implemented that:
- a. Address the applicable requirements in R9-7-1407, R9-7-1408, and R9-7-1411;
- b. Include procedures to ensure that the prescribing health professional orders the use of a medical laser or intense pulsed light device;
- c. If applicable, cover situations in which the prescribing health professional is not present in the facility, according to subsection (C)(8); and
- d. Cover the knowledge, skills, and experience of individuals authorized to use the medical laser or intense pulsed light 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 intense pulsed light device, including follow-up instructions for the patient;
- b. Reviews and, as necessary, revises the written protocols in subsection (C)(3)(a) at least annually; and
- c. Documents the review in subsection (C)(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 intense pulsed light device is only used by:
- a. A health professional described in A.R.S. § 32-3233(D)(1) who meets the requirements in subsection (D);
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 as specified in A.R.S. § 32-3233(D)(1) 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 as specified in A.R.S. § 32-3233(D)(1) and (H)(2);
c. A laser technician, certified under 9 A.A.C. 16, Article 7, for hair removal only, who is receiving hands-on training in the use of a medical laser or intense pulsed light device for a cosmetic procedure other than hair removal under the supervision of:
- i. A health professional who is qualified according to A.R.S. § 32-3233 and subsection (D) and who is present in the room with the laser technician; or
- ii. Another laser technician, who is certified under 9 A.A.C. 16, Article 7, with a minimum of 100 hours of hands-on experience using the medical laser or IPL intense pulsed light device for the cosmetic procedure; who is present in the room with the laser technician receiving hands-on training; and who is receiving direct supervision from a prescribing health professional;
d. An individual who has a provisional certificate for course completion issued according to R9-7-1415(E)(3) and is receiving hands-on training in the use of a medical laser or intense pulsed light device for hair removal under the supervision of:
- i. A health professional, who is qualified according to A.R.S. § 32-3233 and subsection (D) and who is present in the room with the individual; or
- ii. A laser technician, who is certified under 9 A.A.C. 16, Article 7, with a minimum of 100 hours of hands-on experience using the medical laser or IPL intense pulsed light device for hair removal; who is present in the room with the individual; and who is receiving indirect supervision from a prescribing health professional; or
e. An individual who has a provisional certificate for course completion issued according to R9-7-1415(E)(3), has documentation of successful completion of at least 24 hours of hands-on training in the use of a medical laser or intense pulsed light device for hair removal according to R9-7-1415(F)(2) and (G), and is receiving hands-on training for a cosmetic procedure other than hair removal under the supervision of:
- i. A health professional, who is qualified according to A.R.S. § 32-3233 and subsection (D) and who is present in the room with the individual; or
- ii. A laser technician, who is certified under 9 A.A.C. 16, Article 7, with a minimum of 100 hours of hands-on experience using the medical laser or IPL intense pulsed light device for the cosmetic procedure; who is present in the room with the individual; and who is receiving direct supervision from a prescribing health professional;
- 6. Ensure that a laser technician follows the applicable written protocol established by the prescribing health professional according to subsection (C)(3)(a) when applying radiation to a patient using the medical laser or intense pulsed light 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 (C)(3)(a); and
- b. Documents the observation and the assessment in subsection (C)(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 intense pulsed light 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 R9-7-1407(H);
- 11. Comply with R9-7-1411; and
12. Maintain on the premises of the facility:
- a. The policies and procedures in subsection (C)(2);
- b. The written protocols in subsection (C)(3)(a);
- c. Documentation of the review of the written protocols in subsection (C)(3)(b) for at least three years after the date of the review;
- d. Documentation of the observation and assessment in subsection (C)(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 for an individual, required in subsection (C)(1)(b), for as long as the individual is acting as a Laser Safety Officer.
D. A registrant shall verify that a health professional, including a prescribing health professional, is qualified to perform a cosmetic procedure using a medical laser or intense pulsed light device by obtaining documentation that the health professional:
- 1. Meets the requirements in A.R.S. § 32-3233(D)(1); and
2. Has:
- a. Documentation of completing at least 24 hours of didactic training on the subjects in R9-7-1413; or
- b. Been in practice since before October 1, 2010 and has at least 24 hours of training on the subjects in R9-7-1413.
E. If a registrant is using a radiofrequency source that is a FDA-designated Class II medical device for performing a cosmetic procedure, the registrant shall:
1. Ensure that policies and procedures are developed, documented, and implemented that:
- a. Address the requirements in R9-7-1404(B)(2) and (3) and (E);
- b. Include procedures to ensure that the prescribing health professional orders the use of a radiofrequency source; and
- c. Cover the knowledge, skills, training, and experience of individuals authorized to use the radiofrequency source;
2. 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 radiofrequency source, including follow-up instructions for the patient;
- b. Reviews and, as necessary, revises, the written protocols in subsection (E)(2)(a) at least annually; and
- c. Documents the review in subsection (E)(2)(b) with a signature and date of signature;
- 3. Ensure that the registrant has a written order from the prescribing health professional before the application of radiofrequency radiation to a patient;
- 4. Ensure that the radiofrequency source is only used by an individual who meet the requirements in subsection (E)(1)(c);
- 5. Ensure that an individual applying radiofrequency radiation to a patient follows the applicable written protocol established by the prescribing health professional; and
6. Maintain on the premises of the facility:
- a. The policies and procedures in subsection (E)(1),
- b. The written protocols in subsection (E)(2)(a),
- c. Documentation of the review of the written protocols in subsection (E)(2)(b) for at least three years after the date of the review, and
- d. Documentation that an individual using a radiofrequency device for performing a cosmetic procedure meets the requirements in subsection (E)(1)(c) for at least three years after the last date of employment.
F. A registrant shall:
- 1. Provide radiation safety training, specific to the facility and separate from training requirements in R9-7-1404(B)(2), R9-7-1408(C)(3), R9-7-1413, or R9-7-1415, as applicable, to all individuals involved with performing cosmetic procedures with a device that produces nonionizing radiation under subsection (C) or (E), 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 device that produces nonionizing radiation is secured so that the device cannot be removed from the facility; and
- 2. The on/off switch is turned to the “off” position with the key removed or otherwise disabled, such as through requiring the entry of a code before use, so the device cannot be operated while a health professional or other individual authorized to use a device that produces nonionizing radiation is not present in the room where the device is located.
Historical Note
New Section R9-7-1414 recodified from R12-1-1414 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).
Section R9-7-1414 repealed; new Section R9-7-1414 renumbered from R9-7-1438 and amended by final expedited rulemaking at 32 A.A.R. 721 (March 27, 2026, Issue 13) with an immediate effective date of March 5, 2026 (Supp. 26-1).