FDA 510(k) ClearanceGEI
Boston iFace (Boston iFace)
FDA 510(k) K251988 · Boston Aesthetics, Inc.
Clearance details
Ask AI- 510(k) number
- K251988
- Device name
- Boston iFace (Boston iFace)
- Applicant
- Boston Aesthetics, Inc.
- Product code
- GEI
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 878.4400
- Advisory committee
- SU
- Medical specialty
- General, Plastic Surgery
Candidate predicate devices
Ask AIOther devices cleared under product code GEI form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | |
| K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | |
| K262364 | Ellian Enigma RF Device | Ellian Corp | |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | |
| K253504 | Volnewmer™ | Classys, Inc. | |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation |
With a free account
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow, so predicate strategy, testing evidence, and labeling stay aligned before FDA review.