Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cell Robotics, Inc. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
234 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033799CLINICAL LASETTE P-200Cell Robotics, Inc.2003-12-22170
K021946CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEMCell Robotics, Inc.2002-09-11900
K983673LASETTECell Robotics, Inc.1999-01-15870
K981746CELL ROBOTICS' LASETTECell Robotics, Inc.1998-12-072030
K982230LASETTE LASER SKIN PERFORATORCell Robotics, Inc.1998-09-241770
K981149LASETTE LASER SKIN PERFORATORCell Robotics, Inc.1998-06-29900
K973431LASETTECell Robotics, Inc.1997-10-28480
K965124LASETTECell Robotics, Inc.1997-08-142340
K970461CELL ROBOTICS ER: YAG SURGICAL LASERCell Robotics, Inc.1997-07-111550

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda