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) |