ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
FDA 510(k) clearance K182453 · decided 2019-01-11
Clearance details
- K-number
- K182453
- Device name
- ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
- Applicant
- I-Tech Industries Srl
- Decision
- Substantially Equivalent
- Date received
- 2018-09-07
- Decision date
- 2019-01-11
- Days to decision
- 126 days
- Clearance type
- Abbreviated
- Product code
- NUV
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Lazzaro Di Savena, IT
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| T-SHAPE 2 (K231092) | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 |
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| VELASHAPE (K122579) | Syneron Medical, Ltd. | 2012-09-13 |
| MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (K101147) | Alma Lasers, Inc. | 2011-01-21 |
| I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (K101366) | Chromogenex Technologies, Ltd. | 2010-09-17 |
| SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V (K100230) | Eleme Medical, Inc. | 2010-04-02 |
| CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K092195) | Cutera, Inc. | 2009-10-01 |
| REACTION SYSTEM (K090221) | Viora , Ltd. | 2009-07-01 |
| SMOOTHSHAPES (K083629) | Eleme Medical, Inc. | 2009-02-19 |
| ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (K082622) | Alma Lasers , Ltd. | 2009-01-12 |
Recalls involving this device
No recalls on record reference this clearance.