Cleared Traditional

K162053 - PhotonBlade

K162053 is the FDA 510(k) clearance for PhotonBlade by Invuity, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K162053 · Invuity, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
52d
Days
Class 2
Risk

K162053 is an FDA 510(k) clearance for the PhotonBlade. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Invuity, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 15, 2016 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Invuity, Inc. devices

Submission Details

510(k) Number K162053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date September 15, 2016
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1119
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K162053.
PK AIM
K161825 · Gyrus Acmi, Inc. · Sep 2016
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
K161804 · Covidien · Sep 2016
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
K162047 · Covidien · Sep 2016
Enseal X1 Large Jaw Tissue Sealer
K160554 · Ethicon Endo-Surgery, LLC · Sep 2016
Arthrex Synergy RF System
K161581 · Arthrex, Inc. · Sep 2016
Werewolf RF20000 Controller, FLOW 50 Wand
K162074 · ArthroCare Corporation · Aug 2016