510(k) · Cleared
ClearedIpulselight Ipl System, Models HS 300C and HS 650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Apolo Medical Technologies Co., Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jan 18, 2011 as substantially equivalent to K082484 (Genesis Biosystems, Inc., 2008) after a 421-day review. Its family tree reaches back 10 generations to 1992. 24 later devices descend from it.
- Decided
- Jan 18, 2011
- Review
- 421 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910422 (1992). 89 ancestors in all, the oldest K885026 (1989). 24 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 2 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 1 generation backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- This deviceK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- Descendant · cites it directly · 16 of its ownK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 5 of its ownK161286 IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK192521 Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK131859 Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 5 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 4 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 3 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 2 generations backK053324 Chromolite SystemChromogenex Plc · 2006
- 1 generation backK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- This deviceK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013 · cites it directly16descendants
- K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020 · cites it directly5descendants
- K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016 · 2 generations on5descendants
- K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019 · 2 generations on3descendants
- K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd. · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −3 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −2 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| −1 | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| 0 (this device) | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011 | — |
| +1 | K122995 | Intense Pulsed Light (Ipl) Systems | Beijing Kes Biology Technology Co., Ltd. | 2013 | — |
| +1 | K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +2 | K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| +2 | K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
| +1 | K131859 | Multifunctional Series | Beijing Honkon Technologies Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 18.1 · 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? (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 |
|---|---|---|---|
| * | K082484 | Accelawave SystemSummary page 2…general and plastic surgery and in dermatology (per 21 CER Part 878.4810). Device classification: C lass I1. Product code: GEX Predicate devices: Accelawave System (K082484) Comparison of Ellipse!I PL to predicate devices: ______________ iPulse Li ght IP L ( HS- 650 & H S-300C)… | 2008 |
What descends from it? (24)
See all 244 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 19 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 89 ancestors have a recall of any class.
- Of its descendants, K122995 (Beijing Kes Biology Technology Co., Ltd., 2013) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K082484.
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. 2011, 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?
iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions: . Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen. *Treatment of: - Moderate inflammatory acne vuigaris - Benign pigmented epidermal…
Read the full statement (234 words)
iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
. Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.
*Treatment of:
- Moderate inflammatory acne vuigaris
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
- Cutaneous lesions including scars
- Benign cutaneous vascular lesions including port wine stains, heniangiomnas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins, spider anglomas and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.
- Reduce pain during light treatment (via partial anesthesia from cooling)
- Reduce discomfort during and/or associated with light treatment
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment. thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation
- Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
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/K093627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093627: Ipulselight Ipl System, Models HS 300C and HS 650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093627
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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