510(k) · Cleared
ClearedPhotodynamic Therapy (PDT) Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shangdong Huamei Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on May 21, 2020 as substantially equivalent to K190938 (Shanghai Apolo Medical Technology Co., Ltd., 2019) after a 59-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- May 21, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K943450 (1995). 93 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK120460 SmartluxMedmix Co., Ltd. · 2012
- 1 generation backK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- This deviceK200751 Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK230342 Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK120460 SmartluxMedmix Co., Ltd. · 2012
- 1 generation backK190938 Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2019
- This deviceK200751 Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K120460 | Smartlux | Medmix Co., Ltd. | 2012 | — |
| −1 | K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K200751 | Photodynamic Therapy (PDT) Equipment | Shangdong Huamei Technology Co., Ltd. | 2020 | — |
| +1 | K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K190938 | Phototherapy SystemSummary page 5…) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device. 5. Identification of Predicate Device(s) K190938 Phototherapy System Shanghai Apolo Medical Technology Co., Ltd. 6. Non-Clinical Test Conclusion Non clinical… | 2019 |
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 |
|---|---|---|---|
| K230342 | Phototherapy System (OL-PDT950) | 2023 | 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 25 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 3 of the 93 ancestors have a recall of any class.
- Of its descendants, K230342 (Shanghai Omni Laser Skinology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K190938.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (630nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The…
Read the full statement (102 words)
The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (630nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200751: Photodynamic Therapy (PDT) Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200751
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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