510(k) Report

510(k) · Cleared

Cleared

LYFT

K180888510(k) TraditionalCleared Aug 30, 2018148-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Uplevity, Inc. · OLP Over-The-Counter Powered Light Based Laser For Acne

Cleared on Aug 30, 2018 as substantially equivalent to K132833 (Accord Media, 2014) after a 148-day review. Its family tree reaches back 1 generation to 2014.

Decided
Aug 30, 2018
Review
148 days
Class
Class II
Product code
OLP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K132833 (2014). No later device cites it as a predicate yet.

K132833 · Ultra Renew Plus · Accord Media · 2014 · recalled201020122014201620182020
K132833 · Ultra Renew Plus · Accord Media · 2014 · recalled0
  1. Root · 1 generation backK132833 Ultra Renew PlusAccord Media · 2014 · Recalled
  2. This deviceK180888 LYFTUplevity, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K132833Ultra Renew PlusAccord Media20144
0 (this device)K180888LYFTUplevity, Inc.2018—
FIG. 1 — Lineage of K180888, 2014–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OLP? 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 OLP device

  1. #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K132833Ultra Renew Plus
Summary page 4
…Powered Light Based Laser For Acne Regulation Number: 21 CFR 878.4810 Regulatory Class: Class II Product Code: OLP Predicate Device(s): Ultra Renew Plus (K132833) Device Description: The LYFT is a hand-held, rechargeable Li-Polymer battery powered device used for the treatment of mild to…
Accord Media20144

Also cleared against K132833: 2 other devices →

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?

  • Its one ancestor has a recall.
  • 2 other devices also cite its predicate K132833.

How does its category compare?

All OLP devices

OLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OLP

3in 2025

2009: 12010: 32012: 22013: 32014: 32015: 32016: 62017: 42018: 52019: 22020: 12021: 62022: 52023: 32025: 32026 (partial year): 1
2007high 6 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLP

88in 2025

2010: 247 days median2013: 245 days median2014: 255 days median2015: 159 days median2016: 99 days median2017: 151 days median2018: 104 days median2021: 260 days median2022: 245 days median2023: 109 days median2025: 88 days median
2007high 260 (2021) · low 88 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLP

4in 2017

2017: 4
2007high 4 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OLP

1in 2025

2014: 12016: 12017: 12018: 72019: 192020: 82021: 72022: 12023: 22024: 12025: 1
2007high 19 (2019) · low 0 (2007)2025

MAUDE reports naming product code OLP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
2010324700
20110—00
20122—00
2013324500
2014325501
2015315900
201669901
2017415141
2018510407
20192—019
20201—08
2021626007
2022524501
2023310902
20240—01
202538801
20261—0—

What is it indicated for?

The LYFT device is intended to be used:

LED functional mode

To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face.

To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.

Micro Vibration functional mode

As an electrically powered device intended for medical purposes to relieve minor aches and pains.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K180888: LYFT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180888

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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