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Board adopts modified radio-frequency rule language to permit nonsurgical dry-eye devices, clears 15-day notice
Summary
The board voted to send modified regulatory text on radio‑frequency devices for dry‑eye treatment out for a 15‑day public comment period after adding frequency and temperature‑monitoring limits and clarifying the nonsurgical purpose.
The California State Board of Optometry voted to approve modified regulatory text intended to allow the use of specified radio‑frequency (RF) devices for the treatment of dry‑eye disease or syndrome and to send that revised language out for a 15‑day public‑comment period.
The modified proposal narrows the allowed technology to devices used specifically to treat dry‑eye disease or syndrome, sets a frequency range, and requires temperature monitoring or predefined temperature presets to prevent tissue ablation. Board staff said the change was designed to distinguish nondestructive RF devices used in ocular surface care from RF or electrosurgical units that ablate tissue and are considered surgical.
Why it matters: Several companies and clinics have sought clarity about whether RF-based devices can be lawfully used by optometrists in California. The board's action aims to permit access to RF-based dry‑eye therapies while spelling out technical controls (frequency band and temperature safeguards) that, according to staff, keep the devices in the realm of nonsurgical, office‑based treatment.
Public comment and discussion: The board heard both support and opposition during a public‑comment period and at the meeting. The California Optometric Association told the board it had no objection to the revised language. Physician groups, including the California Academy of Eye Physicians and Surgeons and the California Medical Association, urged the board to withdraw the proposal, arguing RF-induced collagen formation (neocollagenesis) alters tissue and therefore constitutes "surgery" under the optometry practice act. Board counsel advised that, on review of case law and statutory definitions, the proposed RF applications do not meet the legal definition of surgery.
The board approved a motion directing staff to publish the modified regulatory text for 15 days of public comment. If no adverse comments are received during that period, the executive officer is authorized to complete the rulemaking steps and adopt section 1572 with the modified text. The board's motion included authorization for the executive officer to make technical, non‑substantive edits before filing.
Next steps: The modified rule will be published for a 15‑day comment period. If adverse comments are submitted, the board must consider them at a future meeting. If no adverse comments are received, staff will complete the remaining steps in the formal rulemaking process and file the regulation.
