California optometry board advances draft rule to allow radio‑frequency dry‑eye devices, with limits

The California State Board of Optometry on April 15 voted to send modified regulations on radio‑frequency devices used to treat dry‑eye disease out for a 15‑day public‑comment period, approving language that narrows the device uses, specifies a frequency range and requires temperature monitoring or temperature presets.

The board’s modified text replaces language about "heating the tissue" with language that explicitly limits the rule to devices "used for the purpose of treating dry eye disease or syndrome," and adds controls to ensure surface temperatures remain below limits intended to exclude devices that ablate tissue or are used as electrical surgical units.

Board Executive Officer Gregory Pruden described the edits as intended "to make clear that this technology is used for the purpose of treating dry eye disease or syndrome," and to ensure the rule "rules out other devices that use RF and ablate the tissue." Regulatory counsel Elizabeth Dietzen Olsen told the board she had reviewed case law and definitions and did not find that the radio‑frequency therapy at issue here met the statutory definition of surgery.

Supporters — including several optometrists who submitted letters and testified virtually — told the board RF therapies are widely used elsewhere, non‑invasive and useful for meibomian gland dysfunction and other contributors to dry eye. Opponents, including representatives of physician groups, argued RF stimulates collagen (neocollagenesis) and thus alters tissue, which they said should fall outside the practice of optometry under the statute. Ophthalmology representatives asked the board to investigate clinics already offering RF treatment and discipline any unlawful practice before the rules take effect; the board did not direct such an investigation as part of this vote.

The board’s approved motion, moved by Member Clepa and seconded by Dr. Wong, directs staff to publish the modified text and responses to comments, start a 15‑day public comment period on the revised language, and, if no adverse comments are received on that modified text, to complete the rulemaking. The roll‑call vote was recorded as unanimous by members present.

If the package is finalized after the 15‑day notice and any additional steps required by the Administrative Procedure Act, the rule would be codified at title 16, California Code of Regulations, section 1572 (as proposed) with the temperature and frequency limits included in the final regulatory text. The board also authorized the executive officer to make technical and non‑substantive edits to the rulemaking package.