Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NUV — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
113 daysmedian FDA review time
234 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 | 157 | 0 |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | 2021-06-22 | 56 | 0 |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LAS | I-Tech Industries Srl | 2019-01-11 | 126 | 0 |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | 2017-03-02 | 234 | 0 |
| K131362 | INMODE WMBODY DEVICE | Inmode MD , Ltd. | 2013-10-08 | 148 | 0 |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | 2012-09-13 | 21 | 0 |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SY | Alma Lasers, Inc. | 2011-01-21 | 273 | 0 |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010-09-17 | 123 | 0 |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010-04-02 | 66 | 0 |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2009-10-01 | 72 | 0 |
| K090221 | REACTION SYSTEM | Viora , Ltd. | 2009-07-01 | 152 | 0 |
| K083629 | SMOOTHSHAPES | Eleme Medical, Inc. | 2009-02-19 | 73 | 0 |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | 2009-01-12 | 125 | 0 |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2008-04-08 | 63 | 0 |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | 2007-08-22 | 47 | 0 |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2007-07-27 | 198 | 0 |
| K061603 | SMOOTHSHAPES | Biocellulase, Inc. | 2006-07-03 | 25 | 0 |
| K053611 | SMOOTHSHAPES | Bicellulase, Inc. | 2006-03-15 | 78 | 0 |
| K050397 | VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2005-06-09 | 113 | 0 |
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