California optometry board hears widespread support and legal concerns about authorizing radio‑frequency devices for dry‑eye care

The California State Board of Optometry on Feb. 14 heard more than a dozen public commenters supporting a proposed regulation to authorize optometrists to use noninvasive radio‑frequency (RF) devices to treat meibomian gland dysfunction and dry‑eye disease, while representatives of physician groups argued the devices could meet the statutory definition of “surgery.”

Board President Garcia introduced agenda item 3 and staff said the board had submitted a regulatory proposal to the Office of Administrative Law and had received “numerous comments in support and 2 comments in opposition” during the public notice period. Executive Officer Gregory Pruden told the board the item was being presented to receive additional oral and written comment before any final regulatory action.

The board heard repeated testimony that RF devices are noninvasive and safe. William Fleischman, an optometrist practicing in Rio Linda, said: “The technique is a very simple procedure. It's safe and effective, and there is no reason that we should not be allowed to use it.” Sebastiano Santarelli, who identified himself as a representative of INMODE, said his company’s ocular RF device had been on the market for seven years and “to date, there have been no reported adverse events.”

Multiple academic and clinical leaders also testified in support. Elizabeth Hoppe, dean of the College of Optometry at Western University of Health Sciences, told the board authorizing RF would “increase patient access, especially in underserved areas where ophthalmologists may not be readily available.” Mark McConnell, associate dean at the Southern California College of Optometry, cited curriculum inclusion and NIH‑funded studies when endorsing the technology.

Representatives of organized medicine urged caution. Michael Kouras, an ophthalmologist in San Diego, told the board the legislature conditioned the board’s new authority on ensuring any newly permitted technology not conflict with the statutory definition of surgery. Kouras and Alicia Sanchez of the California Medical Association argued the RF effect on tissue (they referenced “neocologenesis” in testimony) could be read to “alter tissue” and therefore fall outside the board’s regulatory authority under Business and Professions Code provisions cited during the meeting.

Board members raised legal and technical questions rather than taking immediate action. Member Clapot (board member) asked staff to search for any case law or regulatory guidance that clarifies the contested statutory phrase “otherwise infiltrated by any means” as used in Business and Professions Code §3041(b)(5)(B) (the statutory definition of “surgery” cited in public comment). Member Linden and others asked staff to also review the Food and Drug Administration approvals for these devices and whether FDA findings discussed invasive vs. noninvasive use might inform the board’s response.

Executive Officer Pruden said the board did not intend to amend the regulatory text at this meeting and that staff would respond to comments as part of the existing rulemaking record. He described next steps: the department will research the statutory language and FDA materials, the board will prepare written responses to the public comments, and the item will return for further consideration at the April board meeting. Pruden emphasized the board’s proposal would not permit optometrists to delegate RF treatments to unlicensed persons and said the proposal includes consumer protections.

The board did not vote or adopt regulatory language at the Feb. 14 meeting. Instead, it directed staff to gather legal authorities and FDA information, to prepare responses to the public comments already in the record, and to present the findings at a future meeting.

Why it matters: Hundreds of thousands of Californians suffer from dry‑eye disease; the question on the table is whether optometrists’ existing scope of practice and the statute’s language permit the board to authorize a noninvasive RF treatment through regulation. The decision would change who may deliver an increasingly common therapy and shape patient access in regions with fewer ophthalmologists.

Public comment and next steps: The board’s record includes testimony from practicing optometrists, optometry school deans, device company representatives, nursing‑union representatives and physician organizations. The board asked staff to research whether (1) case law or regulatory interpretation clarifies the statute’s phrase “otherwise infiltrated by any means,” and (2) the FDA’s clearance language for RF devices discusses invasiveness in ways that would bear on the statutory issue. Staff will prepare written responses to the 45‑day public comments and return the item to the board at its April meeting for possible action.