510(k) · Cleared
ClearedForma System, Forma Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Formatk Systems, Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Apr 15, 2016 as substantially equivalent to K090221 (Viora, Ltd., 2009) and 1 other predicate after a 79-day review. Its family tree reaches back 19 generations to 1992.
- Decided
- Apr 15, 2016
- Review
- 79 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K910422 (1992). 340 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations between
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- This deviceK160195 Forma System, Forma Light SystemFormatk Systems, Ltd. · 2016
Show all 19 generations
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 18 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 17 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 16 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 15 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 14 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 13 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 12 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 11 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 10 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 9 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 8 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 7 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 6 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 5 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 4 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- This deviceK160195 Forma System, Forma Light SystemFormatk Systems, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −18 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −17 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −16 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −15 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −14 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −13 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −12 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −11 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −10 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −9 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −8 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −7 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −6 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −5 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −4 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −2 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −1 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| 0 (this device) | K160195 | Forma System, Forma Light System | Formatk Systems, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 8 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 25 | 0 |
| 1998 | 20 | 0 |
| 1999 | 13 | 0 |
| 2000 | 27 | 0 |
| 2001 | 27 | 0 |
| 2002 | 34 | 0 |
| 2003 | 32 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K090221 | Reaction SystemSummary page 6…devices: Manufacturer Device 510(k) No. Viora Ltd. Viora Reaction System K090221 Lumenis Ltd. Lumenis M22 System K142860 The Forma Light System is substantially equiva… | 2009 |
| * | K142860 | Lumenis M22 SystemSummary page 6…510(k) No. Viora Ltd. Viora Reaction System K090221 Lumenis Ltd. Lumenis M22 System K142860 The Forma Light System is substantially equivalent to the following predicate device: Manufacturer… | 2015 |
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 24 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 340 ancestors have a recall of any class.
- 6 other devices also cite its predicate K090221.
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. 2016, 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 Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology. The Forma System and Forma Light System** have connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1) The Forma System and Forma Light System** with the Intense Pulsed Light (IPL)…
Read the full statement (309 words)
The Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology.
The Forma System and Forma Light System** have connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
1) The Forma System and Forma Light System** with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm are indicated for:
HR*, F-HR*, B-HR* Applicators (650-1100nm):
* Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction® in skin types I-V through selective targeting of melanin in hair follicles.
HR, F-HR, B-HR Applicators (590-1100nm):
* Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.
SR, F-SR, B-SR Applicators (530-1100nm):
* Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
* Cutaneous lesions, including striae
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
F-AC Applicator (430-1100nm):
* Mild to moderate inflammatory Acne (Acne vulgaris)
2) The Forma System with the ST Handpiece (Radio Frequency) is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
3) The Forma System with the PLG Handpiece (Microdermabrasion Applicator) is indicated for skin dermabrasion.
Notes:
* Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
** The Forma Light System is a desktop model of the Forma System and is based on IPL technology only.
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/K160195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160195: Forma System, Forma Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160195
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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