510(k) · Cleared
ClearedHemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Energy Medical Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 18, 2026 as substantially equivalent to K252745 (Micro-Energy Medical Technology Co., Ltd., 2025) after a 27-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- Jun 18, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 26 generations to K943450 (1995). 405 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations between
- 3 generations backK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- 2 generations backK241643 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025
- 1 generation backK252745 Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd. · 2025
- This deviceK261701 Hemolase Fiber…Micro-Energy Medical Technology Co., Ltd. · 2026
Show all 26 generations
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 25 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 22 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 21 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 20 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 19 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 18 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 15 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 14 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 13 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 12 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 11 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 10 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 9 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 8 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 7 generations backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- 6 generations backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- 5 generations backK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- 4 generations backK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- 3 generations backK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- 2 generations backK241643 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025
- 1 generation backK252745 Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd. · 2025
- This deviceK261701 Hemolase Fiber…Micro-Energy Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −25 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −22 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −21 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −20 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −19 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −18 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −15 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −14 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −13 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −12 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −11 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −10 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −9 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −8 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −7 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| −6 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| −5 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| −4 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| −3 | K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022 | — |
| −2 | K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | 2025 | — |
| −1 | K252745 | Halo Sterile Single-use Radial Fiber… | Micro-Energy Medical Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 8 | 0 |
| 1992 | 6 | 0 |
| 1993 | 11 | 0 |
| 1994 | 29 | 0 |
| 1995 | 21 | 0 |
| 1996 | 26 | 0 |
| 1997 | 30 | 0 |
| 1998 | 29 | 0 |
| 1999 | 19 | 0 |
| 2000 | 29 | 0 |
| 2001 | 31 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 1 | 0 |
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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K252745 | Halo Sterile Single-use Radial Fiber…Summary page 6…tification of Predicate Device(s) The identified predicates within this submission are as follows: Predicate Device : 510(k) number:K252745 Trade name:Halo Sterile Single-use Radial Fiber… | 2025 |
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 31 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 18 of the 405 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Hemolase Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Hemolase Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261701: Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261701
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026