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PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

Stryker Instruments

Country / Region:United States (US)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

United States (US)

Product code

GEI
21 CFR 878.4400

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250483
Device name
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
Country / Region
United States(US)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-02-19
Decision date
2025-09-09
Submission type
Traditional
Technology type
RF Ablation(AI inferred)
Clinical applications
SurgeryTissue RepairPain Management
Primary application
Surgery
Classification source
AI classified

Indications for Use

The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures. The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Intended Use

The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures. The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Device Description

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices. The devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation unit. A cable with a universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

Summary parsed at:2026-06-20 17:48:05 UTC

Predicate devices

1

K250483 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K250483 as a predicate