BETA
Smithfield, Rhode Island medical-device company commercializing UltraClear and AuraLux 2910 nm fiber lasers for dermatology, plastic surgery and aesthetic practices.
Founded in 2018, Acclaro Medical develops and markets energy-based medical devices. Its current public website centers on UltraClear, with Acclaro Corporation identified in FDA records. Leadership includes CEO and co-founder Helen Fang, president and co-founder Shlomo Assa, and Chief Business Development Officer Kassandra Lepack.
The marketed portfolio includes UltraClear and AuraLux 2910 nm fiber-laser brands. Two FDA 510(k) decisions support the UltraClear lineage, with AuraLux listed under the later decision. Branded treatment approaches such as 3DMIRACL and Laser-Coring are grouped within the platform rather than counted as independent cleared devices. A published photodamage pilot study enrolled 37 participants and followed 35 completers; it does not establish broad comparative superiority.
In May 2025, Acclaro announced a $23 million Series B led by Accelmed with participation from 3E Bioventures. Its commercial expansion includes a German subsidiary headquarters in Munich, a MellingMedical federal distribution relationship, and a company-reported Canadian authorization and Xcite distribution agreement. Current annual revenue and installed-base totals remain unconfirmed.
Class II, 21 CFR 878.4810, GEX/ONG. K210847 December 10, 2021 and K233803 May 8, 2024; clearance is not PMA approval or endorsement of every marketing claim. [2][3][4][13][14][15][16][18]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [20][21]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Professional ablative fiber-laser platform. 3DMIRACL and Laser-Coring are treatment approaches within the platform, not separately counted cleared devices. [17][3]
FDA-clearedCommercially available to professional practices; availability varies by market.
Commercial laser brand introduced in April 2025. FDA device listing connects AuraLux to K233803; it is not counted as a separate new clearance. [6][3][4]
FDA-clearedCommercially available to professional practices; availability varies by market.
Commercial expansion includes AuraLux, distribution and international markets. A 37-participant photodamage pilot study supplies limited clinical evidence; it is not a head-to-head superiority trial. [17][6][10][24]
Company reports Health Canada authorization and Xcite Technology commercialization partnership; not independently verified in a Canadian licence record. [8]
Company reports $20M from Accelmed and $3M from 3E Bioventures. Primary release is dated May 29; website archive incorrectly labels March 29. [24]
Launch announcement for the additional 2910 nm laser brand. [6]
Company reports October 28 opening, announced November 4; U.S. headquarters remains identified as Smithfield in current LinkedIn and FDA records. [7]
K233803 covers the labeled dermatologic applications. [3]
MellingMedical announced a route to federal health facilities; this does not establish a procurement award or installed base. [9]
Company archive dates U.S. launch announcement to April 28, 2022. [16]
K210847 issued under former company name FA International, LP. [2]
Accessed 10/29/2026