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Laser Hair Removal Penalties and Sanctions

Health and Safety Code Chapter 401
16 Texas Administrative Code, Chapter 118

Class A Violations

Penalty Range: $500 to $1,500

Administrative Violations

Violation Statute/Rule
Failed to notify the Department in writing within thirty days of a change of name, address, LSO, or employment of certain personnel 118.31(a) & (b)
Failed to provide employees written instructions on how to safely use LHR devices including appropriate warnings and precautions 118.70(i)
Failed to document that employees have read and understand the instructions on how to safely use LHR devices 118.70(j)
Failed to follow proper procedures when a facility terminates all activities involving LHR devices 118.31(j)

Posting and Public Information Violations

Violation Statute/Rule
Failed to publicly display license in the appropriate location 401.513; 118.70(p)
Failed to post for consumers and service recipients a warning sign that LHR may result in adverse effects and/or failed to post notice of the name, mailing address, and telephone numbers of the Department for purposes of directing complaints to the Department 401.516(a); 118.70(q)
Failed to post required signs in the LHR controlled area 118.70(r)

Recordkeeping Violations

Violation Statute/Rule
Failed to provide the Department documentation of LHR facility's contractual relationship with the consulting physician 401.519(b)
Failed to conduct yearly physical inventory of all LHR devices and create and maintain records of these inventories 118.31(e)

Class B Violations

Penalty Range: $1,000 to $2,500 and/or up to one-year full suspension

Administrative Violations

Violation Statute/Rule
Failed to comply with the adverse reporting requirements and notify the Department within 24 hours of submission of such report 118.31(c)

Posting and Public Information Violations

Violation Statute/Rule
Failed to provide customers with written statement advising the relevant risks of LHR including damaging the customers’ eyes 401.515(a); 118.70(n)
Failed to disclose in writing limitations of LHR certificate: not authorized to diagnose, treat, or offer to treat any client for any illness, disease, injury, defect, or deformity of the human body 401.504(b)

Recordkeeping Violations

Violation Statute/Rule
Failed to maintain records of receipt, transfer, and disposal for each LHR device 118.31(f)
Failed to make and maintain records of each audit conducted 118.70(s)
Failed to make and maintain records of each LHR procedure 118.70(t)
Failed to keep records for required retention period 118.100(1); 118.100(2)

Advertising Violations

Violation Statute/Rule
Claimed, advertised, or distributed promotional materials indicating laser hair removal is free from risk or provides any medical benefit 401.518(b); 118.31(h)
Produced false or misleading advertising 401.518(c); 118.31(i)

Facility and Equipment Violations

Violation Statute/Rule
Unauthorized person purchased an LHR device-update language 118.3(l); 118.70(d)
Failed to stop LHR procedures when an LHR facility has loss the services of both designated consulting physicians 118.31(d)

Laser Safety Officer – Designation and Responsibilities

Violation Statute/Rule
Failed to ensure laser safety training for users of LHR devices 118.32(b)(1)
Failed to ensure required audits are conducted 118.32(b)(6)
Failed to maintain required records 118.32(b)(7)

Unlicensed Activity

Violation Statute/Rule
Failed to stop operations of LHR when facility certificate expired 118.40(d)

Class C Violations

Penalty Range: $2,000 to $5,000 and/or up to revocation

Unlicensed Activity

Violation Statute/Rule
Performed or attempted to perform laser hair removal without holding the appropriate certificate 401.504(a); 118.2(c); 118.20(c)
Operated a laser hair removal facility without holding the appropriate certificate 401.510(a) & (b); 118.2(b); 118.20(b); 118.30(b); 118.30(d)
Transferred, assigned, or in any manner disposed of LHR registration to any person 118.31(l);
Transferred, assigned, or in any manner disposed of LHR certificate to any person 118.33(g)
Performed an act or practice for which the issued certificate is not licensed 401.504(b); 118.3(e)

Sanitation, Safety, & Public Health Violations

Violation Statute/Rule
LHR operator failed to ensure the LHR facility complied with requirements of the Act

401.518(a),

118.31(g)

Failed to establish a controlled area on the LHR facility’s premises to secure LHR devices from unauthorized access 118.70(k)
Failed to properly secure each LHR device to prevent unauthorized access 118.70(l)
Failed to require all individuals using an LHR device to wear proper protective eyewear 118.70(m)
Used an LHR device in an unauthorized or unregistered facility 118.70(u)
Used an LHR device for a purpose not authorized in the facility registration 118.70(u)

Ethical Violations

Violation Statute/Rule
Failed to complete required continuing education hours 118.35(a)

Facility and Equipment Violations

Violation Statute/Rule
LHR device failed to comply with all applicable federal and state laws and regulations 401.514(a); 118.3(c); 118.70(b)
Adulterated or misbranded an LHR device 401.514(b); 118.70(c)
Failed to ensure an LHR device categorized as a prescription device complies with federal requirements for prescription use 118.3(k)
Operated an LHR facility from a person’s living quarters 118.20(f)
Improperly made, sold, leased, transferred, or lent LHR devices 118.70(a)

Standard of Care Violations – Supervision

Violation Statute/Rule
Certified laser hair removal professional performed LHR without acting under protocol established with a consulting physician and without supervision 401.505(b)
Laser hair removal apprentice-in-training failed to work under the direct supervision of a senior laser hair removal technician or a certified laser hair removal professional 401.508(b)
LHR facility failed to have a certified laser hair removal professional or a licensed health professional present to supervise LHR procedures 401.517(a); 118.70(g)
LHR facility failed to have a written contract with a consulting physician 401.519(a)
LHR professional failed to audit and ensure direct supervision of each of the LHR procedures performed by an LHR technician while obtaining the requirements of Section 118.33(c) 118.34(c)

Laser Safety Officer – Designation and Responsibilities

Violation Statute/Rule
Failed to ensure performance of maintenance and required safety practices of LHR devices 118.32(b)(3)
Failed to ensure the proper use of protective eyewear and other safety measures 118.32(b)(4)
Failed to ensure compliance with requirements and protocols 118.32(b)(5)
Failed to ensure personnel are trained, certified, and complied with requirements of LHR facility conditions and protocols of the registrant 118.32(b)(8)

Class D Violations

Penalty Range: $3,500 to $5,000 and/or revocation

Violation Statute/Rule
Failed to comply with previous order of Commission/Executive Director 51.353(a); 118.90
Used an LHR device that threatened or endangered occupational or public health and safety 118.20(a)
LSO failed to take control to institute corrective actions in emergency situations or when there are unsafe conditions 118.32(b)(2)
Used an LHR device for unapproved purposes and/or at unsafe settings 401.514(c); 118.70(f)
Improperly disclosed a customer’s record 401.520(a)