BETA
OpClear laparoscopic lens-cleaning technology designed to maintain surgical visualization without repeated scope removal.
Cipher Surgical develops OpClear, a platform that combines automated carbon-dioxide flow with an on-demand saline lens wash at the laparoscope tip. The system addresses fogging, blood and debris that can interrupt visualization during minimally invasive procedures.
Founded in 2010, the company has commercial operations in the United States and a British development history. FDA records document separate OpClear system and platform clearances. These device-specific decisions should not be interpreted as proof of every performance claim made in marketing material.
Mark Alley leads the company as CEO, with founder Andrew Newell serving as executive chairman. Commercialization combines surgeon education, operating-room workflow integration and channel partnerships; Elemental Healthcare publicly documents UK distribution of OpClear.
OpClear has FDA 510(k) decisions K171637 and K221824. The later record identifies the control unit and specified disposable procedure kits; clearance applies to that scope rather than every future platform configuration. [1][6][7][8]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [10][11]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Control unit, compatible scope sheath and procedure kits deliver CO2 and saline lens cleaning. [1][3][4]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Elemental Healthcare [15] | United Kingdom | OpClear platform |
Sources checked October 17, 2026.
FDA substantially equivalent decision for the specified OpClear platform configuration. [4]
Accessed 10/29/2026