510(k) · Cleared
ClearedApollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Syntech Laser CO., LTD. · GEX Powered Laser Surgical Instrument
Cleared on Dec 14, 2012 as substantially equivalent to K080374 (Bios S.R.L., 2008) and 2 other predicates after a 430-day review. Its family tree reaches back 15 generations to 1995. 1 later device descends from it.
- Decided
- Dec 14, 2012
- Review
- 430 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 243 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK113018 Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice…Beijing Syntech Laser CO., LTD. · 2012
- Descendant · cites it directly · 0 of its ownK221766 SolonLmg Lasers Comercio, Importacao E Exportacao Ltda · 2024
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK113018 Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice…Beijing Syntech Laser CO., LTD. · 2012
Most influential descendants
Showing 1 of 1 · See all- K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light… | Beijing Syntech Laser CO., LTD. | 2012 | — |
| +1 | K221766 | Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K080374 | Biosyag Medical SystemSummary page 4…111-3 rket Notification 510(k) Submissi Section [1[ 510(k) Summary Project #: MIDLINK0382010Bd Predicate Device [dentification a. ER:YAG Laser Hanpiece K080374/ Bios ltalia s.r.l/ BIOSYAG MEDICAL SYSTEM b. Long Pulse Nd:Yag Laser Hanpiece K072564/ Alma Laser, Ltd / Harmony XL Multiple A… | 2008 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 4…t #: MIDLINK0382010Bd Predicate Device [dentification a. ER:YAG Laser Hanpiece K080374/ Bios ltalia s.r.l/ BIOSYAG MEDICAL SYSTEM b. Long Pulse Nd:Yag Laser Hanpiece K072564/ Alma Laser, Ltd / Harmony XL Multiple Application Plateform ¢. Q-Switch Nd:Yag Laser Hanpiece K072564/ Alma Laser, Ltd / Harmon… | 2008 |
| * | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Summary page 4…Harmony XL Multiple Application Plateform ¢. Q-Switch Nd:Yag Laser Hanpiece K072564/ Alma Laser, Ltd / Harmony XL Multiple Application Plateform d. IPL Laser Hanpiece K024093/ Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems/ Lumenis, Inc. 111-4 Prmakt~~fc… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221766 | Solon | 2024 | 0 |
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 17 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 243 ancestors have a recall of any class.
- Of its descendants, K221766 (Lmg Lasers Comercio, Importacao E Exportacao Ltda, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Apollo V+ Medical platform / Apollo IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece. 1. Er: YAG Laser handpiece: Incision, excision, ablation, vaporization of soft tissue The non-ablative treatment of…
Read the full statement (229 words)
Apollo V+ Medical platform / Apollo IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
1. Er: YAG Laser handpiece:
Incision, excision, ablation, vaporization of soft tissue
The non-ablative treatment of facial wrinkles
2. Long pulse Nd:YAG Laser handpiece:
Removal of unwanted hair, for stable long term or permanent hair reduction, and for treatment of PFB.
3. 0-Switched Nd: YAG Laser Hand piece:
1064nm wavelength
Tattoo removal: Dark ink: (Black & Blue)
Nevus of Ota
Skin resurfacing procedures for the treatment of acne scars and wrinkles
5. IPL Handpiece:
The Intense Pulse Light wavelength are 515 - 1200nm
HR (Hair removal): 650 - 1200nm
The removal of unwanted hair from skin types I - V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
SR (skin remove): 570-1200nm
The treatment of benign pigmented (epidermal and cutaneous) lesions, such as warts.
VR (Vascular and Pigmented Lesions Removal), 515-1200nm
The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of civatte; leg veins and venous malformations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113018: Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113018
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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