510(k) Report

510(k) · Cleared

Cleared

Alpha Orthopaedics AT3 System

K094041510(k) TraditionalCleared Apr 7, 201098-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alpha Orthopaedics · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 7, 2010 as substantially equivalent to K090580 (Solta Medical, Inc., 2009) and 4 other predicates after a 98-day review. Its family tree reaches back 17 generations to 1995.

Decided
Apr 7, 2010
Review
98 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K943450 (1995). 110 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2005: 5 other ancestors2007: 2 other ancestors2004: 3 other ancestors2003: 6 other ancestors2000: 9 other ancestors1994: 2 other ancestors2006: 1 other ancestor2002: 9 other ancestors2001: 6 other ancestors1999: 4 other ancestors1996: 11 other ancestors1991: 1 other ancestor1985: 2 other ancestors1997: 14 other ancestors1980: 1 other ancestor1995: 4 other ancestors1992: 3 other ancestors1998: 6 other ancestors1990: 1 other ancestor1993: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K070004 · Accent · Alma Lasers, Ltd. · 2007K072699 · Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL · Alma Lasers, Ltd. · 2007K082622 · Alma Lasers Accent B-Shape Massager Handpiece/Module · Alma Lasers, Ltd. · 2009K090580 · Thermage Thermacool NXT System and Accessories · Solta Medical, Inc. · 20091980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 12 other ancestors3 generations back: 10 other ancestors4 generations back: 6 other ancestors5 generations back: 11 other ancestors6 generations back: 21 other ancestors7 generations back: 12 other ancestors8 generations back: 8 other ancestors9 generations back: 8 other ancestors10 generations back: 2 other ancestors K090580 · Thermage Thermacool NXT System and Accessories · Solta Medical, Inc. · 2009K082622 · Alma Lasers Accent B-Shape Massager Handpiece/Module · Alma Lasers, Ltd. · 2009K072699 · Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL · Alma Lasers, Ltd. · 2007K070004 · Accent · Alma Lasers, Ltd. · 2007K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations between
  3. 3 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
  4. 2 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
  5. 1 generation backK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
  6. This deviceK094041 Alpha Orthopaedics AT3 SystemAlpha Orthopaedics · 2010
Show all 17 generations
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  14. 4 generations backK070004 AccentAlma Lasers, Ltd. · 2007
  15. 3 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
  16. 2 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
  17. 1 generation backK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
  18. This deviceK094041 Alpha Orthopaedics AT3 SystemAlpha Orthopaedics · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−16K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−15K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−14K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−13K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−12K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−11K000944Thermage Thermacool SystemThermage, Inc.2000—
−10K013034Modification to: Thermacool IiaThermage, Inc.2001—
−9K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−8K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−7K030142Thermacool TC SystemThermage, Inc.2003—
−6K031671Polaris WRSyneron Medical, Ltd.2003—
−5K051214Aluma Skin Renewal SystemLumenis, Inc.2005—
−4K070004AccentAlma Lasers, Ltd.2007—
−3K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent…Alma Lasers, Ltd.2007—
−2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.2009—
−1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.2009—
0 (this device)K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198520
199010
199110
199230
199310
199420
199540
1996110
1997140
199860
199940
200090
200160
200290
200360
200430
200550
200610
200720
200820
FIG. 1 — Lineage of K094041, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K090580Thermage Thermacool NXT System and Accessories
Summary page 1
…lectrosurgical cutting and coagulation device and accessories Classification: Product Code GEl, Class II, CFR §878.4400 Predicate Devices (Legally e K090580 Thermage ThermaCool NXT System Marketed Device): * K072849 Modification to Thermage ThermaCool System…
Solta Medical, Inc.2009—
*K072849Modification to Thermage Thermacool System
Summary page 1
…ion: Product Code GEl, Class II, CFR §878.4400 Predicate Devices (Legally e K090580 Thermage ThermaCool NXT System Marketed Device): * K072849 Modification to Thermage ThermaCool System * K052778 Thermage ThermaCool Skin Marking Paper…
Thermage, Inc.2008—
*K052778Thermage Thermacool Skin Marketing
Summary page 1
…ly e K090580 Thermage ThermaCool NXT System Marketed Device): * K072849 Modification to Thermage ThermaCool System * K052778 Thermage ThermaCool Skin Marking Paper * K051710 Thermage ThermaCool Coupling Fluid…
Thermage, Inc.2005—
*K051710Thermage Thermacool Coupling Fluid
Summary page 1
…K072849 Modification to Thermage ThermaCool System * K052778 Thermage ThermaCool Skin Marking Paper * K051710 Thermage ThermaCool Coupling Fluid * K013639 Thermage ThermaCool TC System DEVICE DESCRIPTION T…
Thermage, Inc.2005—
*K013639Thermage Thermacool TC System
Summary page 1
…* K052778 Thermage ThermaCool Skin Marking Paper * K051710 Thermage ThermaCool Coupling Fluid * K013639 Thermage ThermaCool TC System DEVICE DESCRIPTION The AT3 TM System delivers RF energy while cooling tissue by conduction. Compon…
Thermage, Inc.2002—

Also cleared against K090580: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 9 months on median.
  • 3 of the 110 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K090580.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The radiofrequency-energy only delivery components of the Alpha Orthopaedlics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:

* General surgical procedures for electrocoagulation and hemostasis

* Relief of minor muscle aches and pain

* Relief of muscle spasms

* Temporary improvement of local circulation (i.e., blood circulation)

Indications for use as stated in the FDA summary.

Also cleared against K090580

3 other devices cite the same predicate.

  • K173759Thermage CPT System and AccessoriesSolta Medical · 20181 recall
  • K170758Thermage FLX System and AccessoriesSolta Medical · 2017
  • K132431Thermage CPT SystemSolta Medical, Inc. · 20131 recall

More from Alpha Orthopaedics

2 FDA decisions under this applicant name. See the company

  • K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics · 2008

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K094041 · printed Nov 6, 2026

Cite this page

510(k) Report. “K094041: Alpha Orthopaedics AT3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094041

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026