510(k) · Cleared
ClearedGSD Intense Pulsed Light System, Models: GP666C4, GP666C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Gsd Tech Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Nov 16, 2009 as substantially equivalent to K083915 (Advanced Technology Laser Co., Ltd., 2009) and 2 other predicates after a 160-day review. Its family tree reaches back 11 generations to 1992. 4 later devices descend from it.
- Decided
- Nov 16, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K910422 (1992). 86 ancestors in all, the oldest K892514 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 2 generations backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- 1 generation backK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- This deviceK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK101901 Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 6 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 5 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 4 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 3 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 2 generations backK051508 Med Flash II Intense Pulsed Light System.General Project S.R.L. · 2005
- 1 generation backK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- This deviceK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · cites it directly2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 2 generations on1descendant
- K22079410PLTentech Co., Ltd. · 2022 · 2 generations on0descendants
- K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −4 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −3 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −2 | K051508 | Med Flash II Intense Pulsed Light System. | General Project S.R.L. | 2005 | — |
| −1 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| 0 (this device) | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +1 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +2 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
| +2 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
| +1 | K101901 | Ipl Therapy System | Beijing Starlight Science & Technology Development | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 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 |
|---|---|---|---|
| * | K083915 | Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and Angelite-SDCSummary page 1…ice Class: Class II Submission Purpose: New Device Predicate Device: Angelite Family of Intense Pulsed Light System (K083915) SkinStation System(K030897) Radiancy Mistral Device(K07233… | 2009 |
| * | K030897 | SkinstationSummary page 1…New Device Predicate Device: Angelite Family of Intense Pulsed Light System (K083915) SkinStation System(K030897) Radiancy Mistral Device(K072331) Device Description The GSD Intense Pulsed L… | 2003 |
| * | K072331 | Radiancy Mistral DeviceSummary page 1…Family of Intense Pulsed Light System (K083915) SkinStation System(K030897) Radiancy Mistral Device(K072331) Device Description The GSD Intense Pulsed Light System (GP666C4 and GP666C)… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 86 ancestors has a recall of any class.
- Of its descendants, K102857 (Ahwon Medi Instrument Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083915.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne, treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following: 1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions. 2.…
Read the full statement (104 words)
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne, treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:
1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
2. Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
3. Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091664
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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